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Lansoprazole 30 mg Tablet, Orally Disintegrating, Delayed Release — NDC 43598-561-78 (Billing 43598-0561-78)

by Dr.Reddys Laboratories Inc · 100 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

This is a package of Lansoprazole 30 mg Tablet, Orally Disintegrating, Delayed Release from Dr.Reddys Laboratories Inc, no longer marketed (first marketed Feb 2021), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026; retail pharmacies pay about $2.26 per unit (NADAC). It is this product's only package size.

NDC 43598-0561-78
🏷️ FDA NDC (as labeled) 43598-561-78 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 43598-561-78 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
43598 labeler · 561 product · 78 package
Package marketed since
Feb 1, 2021
Package marketing ended
Sep 30, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 4359856178 3
Medicaid fills, this package
158 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (3)
Class II · Jul 13, 2022 · Terminated — FAILED DISSOLUTION SPECIFICATIONS (Dr. Reddy's Laboratories, Inc.) · FDA recall D-1287-2022
Class II · Jul 13, 2022 · Terminated — FAILED DISSOLUTION SPECIFICATIONS (Dr. Reddy's Laboratories, Inc.) · FDA recall D-1288-2022
Class II · Apr 15, 2022 · Terminated — Failed Dissolution Specifications (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0853-2022
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-561-78
Product NDC 43598-561
11-digit billing NDC 43598056178
NCPDP billing unit EA — each (per item)
RxCUI 351260, 351261
UNII 0K5C5T2QPG
Application # ANDA210465
SPL Set ID 656bc92a-1f95-047d-cd27-724073e63fe6
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors
Physiologic effect Inhibition Gastric Acid Secretion
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2021-02-01
Marketing end 2026-09-30
Route ORAL
Dosage form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Substance LANSOPRAZOLE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 4927004000H330
GPI class Lansoprazole
GCN Seq No 051654
GCN 18993
HICL code 008993
Ingredient (HICL) Lansoprazole
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4J
Therapeutic class — specific (HIC3) Proton-Pump Inhibitors
AHFS code 56:28.36.00
AHFS class Proton-Pump Inhibitors
FDB label name LANSOPRAZOLE DR 30 MG ODT
FDB brand name Lansoprazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051654
  • GCN: 18993
  • GPI-14 (Medi-Span): 4927004000H330
  • HICL (First Databank): 008993
  • AHFS class code: 56:28.36.00
  • RxCUI (RxNorm): 351260
Why two NDCs? The FDA registers this code as 43598-561-78 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43598-0561-78. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name LANSOPRAZOLE DR 30 MG ODT Ingredient Lansoprazole
📖 What it is MedlinePlus · NLM

Prescription lansoprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription lansoprazole is used to treat the damage from GERD in adults and children 1 year of age and older. Prescription lansoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription lansoprazole is also used to treat ulcers...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It lowers stomach acid. Prescription forms treat ulcers, GERD, erosive esophagitis and conditions with too much acid. It is also used with antibiotics for H. pylori. Over-the-count...
  • Take it once a day, before eating, usually in the morning. Swallow capsules whole. Let orally disintegrating tablets dissolve on your tongue without chewing. For over-the-counter u...
  • For heartburn, the over-the-counter label says full effect can take 1 to 4 days, though some people feel relief within 24 hours. It is not meant for instant relief.
  • The most common are diarrhea, belly pain, nausea and constipation. Call your doctor if you get a severe rash, swelling, trouble breathing, diarrhea that will not clear, or muscle s...
📖 Read our full Lansoprazole guide →
9
Nutrient depletion considerations

Lansoprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Lansoprazole nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.256 $2,255.80 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $2.84 $2,837.90 / 1000 tablets
Medicare drug plans payPart D · Q2 2026 $4.48 $4,480.30 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $5.939 $1.838
▼ Down 58% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43598-0561-78 You're viewing this Main listing 100 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 2021-02-01 Sep 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lansoprazole 30 mg 00093-3009-93 Teva 1 tablet $2.256 AB Availability likely —
Lansoprazole 30 mg 00378-6982-88 Mylan 10 tablets $2.256 AB Availability likely —
Lansoprazole 30 mg 16714-0186-02 NorthStar 10 tablets $2.256 AB Discontinued —
Lansoprazole 30 mgthis 43598-0561-78 Dr.Reddys 10 tablets $2.256 AB Discontinued —
Lansoprazole 30 mg 65862-0896-78 Aurobindo 10 tablets $2.256 AB Availability likely —
Lansoprazole 30 mg 68382-0772-77 Zydus 10 tablets $2.256 AB Availability likely —
Lansoprazole 30 mg 72603-0314-10 NorthStar 10 tablets $2.256 AB Availability likely —
Lansoprazole 30 mg 55154-4848-00 Cardinal 1 tablet — AB FDA listed —
Prevacid SoluTab 30 mg 64764-0544-05 Takeda 3 tablets — AB FDA listed —
Lansoprazole 30 mg 70771-1133-04 Zydus 10 tablets — AB FDA listed —
Lansoprazole 30 mg 55154-8340-00 Cardinal 10 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Feb 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Lansoprazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

We couldn’t check the official label right now. The background importer will retry after the temporary source or processing error clears.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDr.Reddys Laboratories Inc
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA210465 (ANDA)
Labeler code43598
First marketedFeb 2021
Product typeHuman Prescription Drug
Portfolio74 products on file

More NDCs from Dr.Reddys Laboratories Inc labeler code 43598

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Lansoprazole delayed-release orally disintegrating tablet is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults. ( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2) Maintenance of healed duodenal ulcers in adults.

( 1.3) Treatment of active benign gastric ulcer in adults. (1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5 ) Risk reduction of NSAID-associated gastric ulcer in adults.

(1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7 ) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8 ) Maintenance of healing of EE in adults.

( 1.9 ) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10 )

1.1Treatment of Active Duodenal Ulcer Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies ( 14.1 ) ].

1.2Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin/clarithromycin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 ) ].

Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, Microbiology section).

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 ) ]. Please refer to the full prescribing information for amoxicillin.

1.3Maintenance of Healed Duodenal Ulcers Lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies ( 14.3 ) ].

1.4Treatment of Active Benign Gastric Ulcer Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies ( 14.4 ) ].

1.5Healing of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks [see Clinical Studies ( 14.5 )] .

1.6Risk Reduction of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies ( 14.6 ) ].

1.7Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patien… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage: See full prescribing information for complete dosing information for lansoprazole delayed-release orally disintegrating tablets by indication and age group and dosage adjustment in patients with severe hepatic impairment. ( 2.1 , 2.2 , 2.3 ) Administration Instructions (2.4) Lansoprazole delayed-release orally disintegrating tablets • Should not be broken or cut. • Should not be chewed. • Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. • See full prescribing information for alternative administration options.

2.1Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets 30 mg Twice daily for 10 or 14 days Amoxicillin 1 gram Twice daily for 10 or 14 days Clarithromycin 500 mg Twice daily for 10 or 14 days Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets 30 mg Three times daily for 14 days Amoxicillin 1 gram Three times daily for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-Associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks † Risk Reduction 15 mg Once daily for up to 12 weeks † Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short -Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks ‡ Maintenance of Healing of Erosive Esophagitis 15 mg Once daily ¶ Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily § * Please refer to the amoxicillin and clarithromycin full prescribing information, Contraindications and Warnings and Precautions sections, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release orally disintegrating tablets for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment.

If there is a recurrence of erosive esophagitis, an additional eight week course of lansoprazole delayed-release orally disintegrating tablets may be considered. § Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated.

Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole delayed-release orally disintegrating tablets for more than four years. ¶ Controlled studies did not extend beyond 12 months.

2.2Recommended Pediatric Dosage by Indication Pediatric Patients 1 to 11 Years of Age In clinical studies, lansoprazole was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if lansoprazole is safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below [see Use in Specific Populations ( 8.4 )] .

Indication Recommended Dose Frequency Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤30 kg 15 mg Once daily for up to 12 weeks >30 kg 30 mg Once daily for up to 12 weeks Pediatric Patients 12 to 17 Years of Age Indication Recommended Dose Frequency Short-Term Treatment of Symptomatic GERD Non-erosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks

2.3Hepatic Impairment The recommended dosage is 15 mg orally daily in patients with severe liver impairment (Child-Pugh C) [see Use in… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 95 words ▾

3 DOSAGE FORMS AND STRENGTHS • Lansoprazole delayed-release orally disintegrating tablets, 15 mg are white to off white, round, flat faced beveled edge, uncoated tablets with orange to dark brown colored speckles,debossed with ‘ ’ on one side and ‘15’ on the other side. • Lansoprazole delayed-release orally disintegrating tablets, 30 mg are white to off white, round, flat faced beveled edge, uncoated tablets with orange to dark brown colored speckles,debossed with ‘ ’ on one side and ‘30’ on the other side. Delayed-release orally disintegrating tablets: 15 mg and 30 mg.

( 3 )

⛔ Contraindications 127 words ▾

4 CONTRAINDICATIONS • Lansoprazole delayed-release orally disintegrating tablets are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2) , Adverse Reactions ( 6 ) ]. • Proton Pump Inhibitors (PPIs), including lansoprazole delayed-release orally disintegrating tablets, are contraindicated with rilpivirine-containing products [see Drug Interactions (7) ]. • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release orally disintegrating tablets, refer to the Contraindications section of their prescribing information.

Patients receiving rilpivirine-containing products. ( 4 , 7 ) Contraindicated in patients with known severe hypersensitivity to any component of the lansoprazole delayed-release orally disintegrating tablets formulations. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response with lansoprazole delayed-release orally disintegrating tablets does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing (5.1) Acute Interstitial Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs. (5.2) Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile -associated diarrhea.

(5.3) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.4) Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue lansoprazole delayed-release orally disintegrating tablets and refer to specialist for evaluation.

(5.6) Cyanocobalamin (Vitamin B12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7) Hypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. ( 5.8) Interactions with Investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.

( 5.9 , 7 ) Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high-dose methotrexate administration, consider a temporary withdrawal of lansoprazole. ( 5.10 , 7 ) Patients with Phenylketonuria: Each 15 mg lansoprazole delayed-release orally disintegrating tablet contains 2.52 mg and each 30 mg lansoprazole delayed-release orally disintegrating tablet contains 5.04 mg of phenylalanine.

( 5.11 ) Fundic Gland Polyps: Risk increases with long-term use, especially beyond 1 year. Use the shortest duration of therapy. ( 5.12 ) Risk of Heart Valve Thickening in Pediatric Patients Less than One Year of Age: Lansoprazole delayed-release orally disintegrating tablets are not recommended in pediatric patients less than 1 year of age.

( 5.13 , 8.4 )

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with lansoprazole delayed-release orally disintegrating tablets does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

5.2Acute Tubulointerstitial Nephritis Acute tubulointerstial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).

Discontinue lansoprazole delayed-release orally disintegrating tablets and evaluate patients with suspected acute TIN [see Contraindications ( 4 )].

5.3Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like lansoprazole delayed-release orally disintegrating tablets may be associated with an increased risk of Clostridium difficile -associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.3 )] • Bone Fracture [see Warnings and Precautions ( 5.4 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 ) ] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6 )] • Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions ( 5.7) ] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.8 )] • Fundic Gland Polyps [see Warnings and Precautions ( 5.12 ) ].

Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories, Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Worldwide, over 10,000 patients have been treated with lansoprazole in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, lansoprazole treatment has been well-tolerated in both short-term and long-term trials.

The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of lansoprazole-treated patients and occurred at a greater rate in lansoprazole delayed-release orally disintegrating tablets-treated patients than placebo-treated patients in Table 1. Table 1: Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled Lansoprazole Studies Body System/ Adverse Reaction Lansoprazole (N= 2768) % Placebo (N= 1023) % Body as a Whole Abdominal Pain 2.1

1.2Digestive System Constipation Diarrhea Nausea 1.0 3.8 1.3 0.4 2.3

1.2Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 and 30 mg of lansoprazole, but higher in the patients who received 60 mg of lansoprazole (2.9, 1.4, 4.2, and 7.4%, respectively). The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of lansoprazole for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with lansoprazole, misoprostol, and placebo was 5, 22, and 3%, respectively. Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with lansoprazole included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.

Additional adverse experiences occurring in less than 1% of patients or subjects who received lansoprazole in domestic trials are shown below: Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain Cardiovascular System - angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation Digestive System – abnormal stools, anorexia, bezoar, cardiospasm,… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with lansoprazole delayed-release orally disintegrating tablets and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 2.

Clinically Relevant Interactions Affecting Drugs Coadministered with Lansoprazole Delayed-Release Orally Disintegrating Tablets and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir,and nelfinavir) when used concomitantly with lansoprazole may reduce antiviraleffect and promote the development of drug resistance.

Increased exposure of other antiretroviral drugs (e.g., saquinavir) when usedconcomitantly with lansoprazole may increase toxicity of the antiretroviraldrugs. There are other antiretroviral drugs which do not result in clinically relevantinteractions with lansoprazole. Intervention: Rilpivirine-containing products: Concomitant use with lansoprazole delayed-release orally disintegrating tablets is contraindicated [ see Contraindications ( 4 )] .

See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with lansoprazole delayed-release orally disintegrating tablets.

See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals: See prescribing information.

Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time.

Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. Methotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.

No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [ see Warnings and Precautions ( 5.10 )] . Intervention: A temporary withdrawal of lansoprazole delayed-release orally disintegrating tabletsmay be considered in some patients receiving high-dose methotrexate. Digoxin Clinical Impact: Potential for increased exposure of digoxin.

Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin.

Theophylline Clinical Impact: Increased clearance of theophylline [ see Clinical Pharmacology ( 12.3 )] . Intervention: Individual patients may require additional titration of their theophylline dosage when lansoprazole delayed-release orally disintegrating tablets are started or stopped to ensure clinically effective blood concentrations. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.

Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving lansoprazole a… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Based on animal data, may cause adverse effects on fetal bone growth and development. (8.1) Pediatrics: Use is not recommended for the treatment of symptomatic GERD in patients 1 month to less than 1 year of age; efficacy was not demonstrated and nonclinical studies have demonstrated adverse effects in juvenile rats. ( 5.13 , 8.4 )

8.1Pregnancy Risk Summary Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment ( see Data ). In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 6.4 times the maximum recommended human dose produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal Day 21 (see Data). These effects were associated with reduction in body weight gain.

Advise pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. If lansoprazole delayed-release orally disintegrating tablets are administered with clarithromycin, the pregnancy information for clarithromycin also applies to the combination regimen. Refer to the prescribing information for clarithromycin for more information on use in pregnancy.

Data Human Data Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use. Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 62 pregnant women administered median daily doses of 30 mg of lansoprazole were compared to a control group of 868 pregnant women who did not take any PPIs.

There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR) =1.04, [95% Confidence Interval (CI) 0.25 to 4.21]. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to lansoprazole in 794 live births. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations Odds Ratio (OR)=1.12, [95% CI 0.86 to 1.45] and for spontaneous abortions OR=1.29, [95% CI 0.84 to 1.97]).

Animal Data No adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 30 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis. A pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with lansoprazole at oral doses of 10 to 100 mg/kg/day (0.7 to 6.4 times the maximum recommended human lansoprazole dose of 30 mg based on AUC [area under the plasma concentration-time curve]) administered during organogenesis through lactation.

Maternal effects observed at 100 mg/kg/day (6.4 times the maximum recommended human lansoprazole dose of 30 mg based on AUC)… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment ( see Data ). In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 6.4 times the maximum recommended human dose produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal Day 21 (see Data). These effects were associated with reduction in body weight gain.

Advise pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. If lansoprazole delayed-release orally disintegrating tablets are administered with clarithromycin, the pregnancy information for clarithromycin also applies to the combination regimen. Refer to the prescribing information for clarithromycin for more information on use in pregnancy.

Data Human Data Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use. Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 62 pregnant women administered median daily doses of 30 mg of lansoprazole were compared to a control group of 868 pregnant women who did not take any PPIs.

There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR) =1.04, [95% Confidence Interval (CI) 0.25 to 4.21]. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to lansoprazole in 794 live births. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations Odds Ratio (OR)=1.12, [95% CI 0.86 to 1.45] and for spontaneous abortions OR=1.29, [95% CI 0.84 to 1.97]).

Animal Data No adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 30 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis. A pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with lansoprazole at oral doses of 10 to 100 mg/kg/day (0.7 to 6.4 times the maximum recommended human lansoprazole dose of 30 mg based on AUC [area under the plasma concentration-time curve]) administered during organogenesis through lactation.

Maternal effects observed at 100 mg/kg/day (6.4 times the maximum recommended human lansoprazole dose of 30 mg based on AUC) included increased gestation period, decreased body weight gain during gestation, and decreased food consumption. The number of stillbirths was increased at this dose, which may have been secondary to maternal toxicity. Body weight of pups was reduced at 100 mg/kg/day starting on postnatal Day 11.

Femur weight, femur length, and crown-rump length were reduced at 100 mg/kg/d… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of lansoprazole delayed-release orally disintegrating tablets have been established in pediatric patients one year to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis. In clinical studies of symptomatic GERD and erosive esophagitis, lansoprazole was not administered beyond 12 weeks in patients one year to 11 years of age. It is not known if lansoprazole delayed-release orally disintegrating tablets are safe and effective if used longer than the recommended duration.

Do not exceed the recommended dose and duration of use in pediatric patients (see Juvenile Animal Toxicity Data). Lansoprazole was not effective in pediatric patients with symptomatic GERD one month to less than one year of age in a multicenter, double-blind, placebo-controlled study. Therefore, safety and effectiveness have not been established in patients less than one year of age.

Nonclinical studies in juvenile rats have demonstrated an adverse effect of heart valve thickening and bone changes at lansoprazole doses higher than the maximum recommended equivalent human dose. Neonate to less than one year of age The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged less than 28 days and one to 11 months. Compared to healthy adults receiving 30 mg, neonates had higher exposure (mean weight-based normalized AUC values 2.04 and 1.88 fold higher at doses of 0.5 and 1 mg/kg/day, respectively).

Infants aged ≤10 weeks had clearance and exposure values that were similar to neonates. Infants aged greater than 10 weeks who received 1 mg/kg/day had mean AUC values that were similar to adults who received a 30 mg dose. Lansoprazole was not found to be effective in a U.S. and Polish four week multicenter, double-blind, placebo-controlled, parallel-group study of 162 patients between one month and less than 12 months of age with symptomatic GERD based on a medical history of crying/fussing/irritability associated with feedings who had not responded to conservative GERD management (i.e., nonpharmacologic intervention) for seven to 14 days.

Patients received lansoprazole as a suspension daily (0.2 to 0.3 mg/kg/day in infants ≤10 weeks of age or 1 to 1.5 mg/kg/day in infants greater than 10 weeks or placebo) for up to four weeks of double-blind treatment. The primary efficacy endpoint was assessed by greater than 50% reduction from baseline in either the percent of feedings with a crying/fussing/irritability episode or the duration (minutes) of a crying/fussing/irritability episode within one hour after feeding. There was no difference in the percentage of responders between the lansoprazole pediatric suspension group and placebo group (54% in both groups).

There were no adverse events reported in pediatric clinical studies (one month to less than 12 months of age) that were not previously observed in adults. Based on the results of the Phase 3 efficacy study, lansoprazole was not shown to be effective. Therefore, these results do not support the use of lansoprazole in treating symptomatic GERD in infants.

One year to 11 years of age In an uncontrolled, open-label, U.S. multi-center study, 66 pediatric patients (one year to 11 years of age) with GERD were assigned, based on body weight, to receive an initial dose of either lansoprazole 15 mg daily if <30 kg or lansoprazole 30 mg daily if greater than 30 kg administered for eight to 12 weeks. The lansoprazole dose was increased (up to 30 mg twice daily) in 24 of 66 pediatric patients after two or more weeks of treatment if they remained symptomatic. At baseline, 85% of patients had mild to moderate overall GERD symptoms (assessed by investigator interview), 58% had non-erosive GERD and 42% had erosive esophagitis (assessed by endoscopy).

After eight to 12 weeks of lansoprazole treatment, the intent-to-treat analysis demonstrated an approximate 50% reduction in frequency and severity of GERD symptoms. Twenty one of 27… [Excerpted — this section continues on DailyMed.]

🧓 Geriatric Use 81 words ▾

8.5Geriatric Use Of the total number of patients (n=21,486) in clinical studies of lansoprazole, 16% of patients were aged 65 years and over, while 4% were 75 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients and other reported clinical experience has not identified significant differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology ( 12.3 ) ].

🆘 Overdosage 101 words ▾

10 OVERDOSAGE Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction. Oral lansoprazole doses up to 5,000 mg/kg in rats [approximately 1,300 times the 30 mg human dose based on body surface area(BSA)] and in mice (about 675.7 times the 30 mg human dose based on (BSA) did not produce deaths or any clinical signs.

In the event of over-exposure, treatment should be symptomatic and supportive. If over-exposure occurs, call your poison control center at 1-800-222-1222 for current information on the management of poisoning or over-exposure.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

12.2Pharmacodynamics Antisecretory Activity After oral administration, lansoprazole was shown to significantly decrease the basal acid output and significantly increase the mean gastric pH and percent of time the gastric pH was greater than three and greater than four. Lansoprazole also significantly reduced meal-stimulated gastric acid output and secretion volume, as well as pentagastrin-stimulated acid output. In patients with hypersecretion of acid, lansoprazole significantly reduced basal and pentagastrin-stimulated gastric acid secretion.

Lansoprazole inhibited the normal increases in secretion volume, acidity and acid output induced by insulin. The intragastric pH results of a five day, pharmacodynamic, crossover study of 15 and 30 mg of once daily lansoprazole are presented in Table 6. Table 6: Mean Antisecretory Effects After Single and Multiple Daily Lansoprazole Dosing Lansoprazole Parameter Baseline Value 15 mg 30 mg Day 1 Day 5 Day 1 Day 5 Mean 24 Hour pH 2.1 2.7* 4* 3.6 † 4.9 † Mean Nighttime pH 1.9 2.4 3* 2.6 3.8 † % Time Gastric pH>3 18 33* 59* 51 † 72 † % Time Gastric pH>4 12 22* 49* 41 † 66 † NOTE: An intragastric pH of greater than four reflects a reduction in gastric acid by 99%. * (p<0.05) vs baseline only. † (p<0.05) vs baseline and lansoprazole 15 mg.

After the initial dose in this study, increased gastric pH was seen within one to two hours with 30 mg of lansoprazole and two to three hours with 15 mg of lansoprazole. After multiple daily dosing, increased gastric pH was seen within the first hour post-dosing with 30 mg of lansoprazole and within one to two hours postdosing with 15 mg of lansoprazole. Acid suppression may enhance the effect of antimicrobials in eradicating Helicobacter pylori (H. pylori).

The percentage of time gastric pH was elevated above five and six was evaluated in a crossover study of lansoprazole given daily, twice daily and three times daily (Table 7). Table 7: Mean Antisecretory Effects After Five Days of Twice Daily and Three Times Daily Dosing Lansoprazole Parameter 30 mg daily 14 mg twice daily 30 mg twice daily 30 mg three times daily % Time Gastric pH>5 43 47 59* 77 + % Time Gastric pH>6 20 23 28 45 + * (p<0.05) vs lansoprazole 30 mg daily + (p<0.05) vs lansoprazole 30 mg daily, 15 and 30 mg twice daily.

The inhibition of gastric acid secretion as measured by intragastric pH gradually returned to normal over two to four days after multiple doses. There was no indication of rebound gastric acidity. Enterochromaffin-like (ECL) Cell Effects During lifetime exposure of rats with up to 150 mg/kg/day of lansoprazole dosed seven days per week, marked hypergastrinemia was observed followed by ECL cell proliferation and formation of carcinoid tumors, especially in female rats.

Gastric biopsy specimens from the body of the stomach from approximately 150 patients treated continuously with lansoprazole for at least one year did not show evidence of ECL cell effects similar to those seen in rat studies. Longer term data are needed to rule out the possibility of an increased risk of the development of gastric tumors in patients receiving long-term therapy with lansoprazole [see Nonclinical Toxicology ( 13.1 ) ]. Other Gastric Effects in Humans Lansoprazole did not sign… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 106 words ▾

12.1Mechanism of Action Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

📦 How Supplied / Storage and Handling 126 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Lansoprazole delayed-release orally disintegrating tablets, 15 mg are white to off white, round, flat faced beveled edge, uncoated tablets with orange to dark brown colored speckles, debossed with ' ' on one side and ‘15’ on the other side. The 30 mg are white to off white, round, flat faced beveled edge, uncoated tablets with orange to dark brown colored speckles, debossed with ' ' on one side and ‘30’ on the other side. The tablets are available as follows: 15 mg tablets: Unit dose packages of 100 (10 x 10) NDC 43598-560-78 30 mg tablets: Unit dose packages of 100 (10 x 10) NDC 43598-561-78 Store at 20° to 25° C (68° to 77° F); [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION The active ingredient in lansoprazole delayed-release orally disintegrating tablet is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.37. Lansoprazole USP has the following structure: Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C.

Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH.

The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole USP is supplied as delayed-release orally disintegrating tablets for oral administration. Lansoprazole delayed-release orally disintegrating tablets are available in two dosage strengths: 15 and 30 mg of lansoprazole USP per tablet.

Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: aspartame 1 , citric acid anhydrous powder, crospovidone, ethyl acrylate and methyl methacrylate copolymer dispersion, glyceryl monostearate, hydroxypropyl methyl cellulose 3cps, hydroxypropyl methyl cellulose 15cps, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, iron oxide red, iron oxide yellow, magnesium carbonate, mannitol, magnesium stearate, methylacrylic acid ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium hydroxide, strawberry guarana flavour, sugar spheres, talc, titanium dioxide, and triehtyl citrate.

1 Phenylketonurics: Lansoprazole Delayed-Release Orally Disintegrating Tablets Contain Phenylalanine 2.52 mg per 15 mg Tablet and 5.04 mg per 30 mg Tablet. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Advise patients to: Acute Tubulointerstitial Nephritis To call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions ( 5.2 ) ]. Clostridium difficile-Associated Diarrhea To immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.3 ) ].

Bone Fracture To report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions ( 5.4 ) ] Severe Cutaneous Adverse Reactions To discontinue lansoprazole delayed-release orally disintegrating tablets and immediately call their healthcare provider for further evaluation [see Warnings and Precautions ( 5.5 ) ]. Cutaneous and Systemic Lupus Erythematosus To immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions ( 5.6 )].

Cyanocobalamin (Vitamin B12) Deficiency To report any clinical symptoms that may be associated with cyanocobalamin deficiency to their healthcare provider, if they have been receiving lansoprazole delayed-release orally disintegrating tablets for longer than three years [see War nings and Precautions ( 5.7 )]. Hypomagnesemia and Mineral Metabolism To report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to their healthcare provider, if they have been receiving lansoprazole delayed-release orally disintegrating tablets for at least three months [see Warnings and Precautions ( 5.8 ) ].

Drug Interactions Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [ see Contraindications ( 4 )] or high-dose methotrexate [ see Warnings and Precautions ( 5.10 )] . Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 ) ].

Administration • Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose. • Lansoprazole delayed-release orally disintegrating tablets should be taken before eating. • Do not crush or chew lansoprazole delayed-release orally disintegrating tablets. • Take lansoprazole delayed-release orally disintegrating tablets at least 30 minutes priorto sucralfate. • Phenylketonurics: Contains Phenylalanine 2.52 mg per 15 mg lansoprazole delayed-release orally disintegrating tablet and 5.04 mg per 30 mg lansoprazole delayed-release orally disintegrating tablet.

Lansoprazole Delayed-Release Orally Disintegrating Tablets • Do not break or cut. • Place the tablet on the tongue; allow it to disintegrate, with or without water, until the particles can be swallowed. Do not chew the particles. • The tablet typically disintegrates in less than one minute. Alternatively, for children or other patients who have difficulty swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be administered with water via oral syringe or NG tube, as described in the Instructions for Use.

Rx only Distributor: Dr. Reddy’s Laboratories Inc., Princeton NJ 08540 Made in India Revised: 07/2023

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Lansoprazole Delayed-Release Orally Disintegrating Tablets (lan soe' pra zole) What is the most important information that I should know about lansoprazole delayed-release orally disintegrating tablets? You should take lansoprazole delayed-release orally disintegrating tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Lansoprazole delayed-release orally disintegrating tablets may help your acid-related symptoms, but you could still have serious stomach problems.

Talk with your doctor. Lansoprazole delayed-release orally disintegrating tablets can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including lansoprazole delayed-release orally disintegrating tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including lansoprazole delayed-release orally disintegrating tablets.

Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away.

You may or may not have a fever. Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer).

Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body).

Some people who take PPI medicines, including lansoprazole delayed-release orally disintegrating tablets, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects.

Lansoprazole delayed-release orally disintegrating tablets can have other serious side effects. See “What are the possible side effects of lansoprazole delayed-release orally disintegrating tablets?” What are lansoprazole delayed-release orally disintegrating tablets? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.

In adults, lansoprazole delayed-release orally disintegrating tablets are used for: 4 weeks for the healing and symptom relief of duodenal ulcers. 10 to 14 days with certain antibiotics to treat an infection caused by bacteria called H. pylori. maintaining healing of duodenal ulcers. Lansoprazole has not been studied beyond 12 months for this purpose. up to 8 weeks for the healing and symptom relief of stomach ulcers. up to 8 weeks for the healing of stomach ulcers in people taking pain medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

Lansoprazole has not been studied beyond 8 weeks for this purpose. reducing the risk of stomach ulcers in people who are at risk of developing stomach ulcers with NSAIDs. Lansoprazole has not been studied beyond 12 weeks for this purpose. up to 8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach.

This may cause a burning feeling in your chest or throat, sour taste or burping. up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 to 16 weeks of lansoprazole delayed-release orally disintegrating tablets for patients whose EE does not improve or whose symptoms ret… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption: Lansoprazole delayed-release orally disintegrating tablets contain an enteric-coated granule formulation of lansoprazole (because lansoprazole is acid-labile), so that absorption of lansoprazole begins only after the granules leave the stomach. The mean peak plasma levels of lansoprazole occur at approximately 1.7 hours. After a single-dose administration of 15 to 60 mg of oral lansoprazole, the peak plasma concentrations (C max ) of lansoprazole and the area under the plasma concentration curves (AUCs) of lansoprazole were approximately proportional to the administered dose.

Lansoprazole does not accumulate and its pharmacokinetics are unaltered by multiple dosing. The absolute bioavailability is over 80%. In healthy subjects, the mean (±SD) plasma half-life was 1.5 (±1) hours.

Both the C max and AUC are diminished by about 50 to 70% if lansoprazole is given 30 minutes after food, compared to the fasting condition. There is no significant food effect if lansoprazole is given before meals. Distribution : Lansoprazole is 97% bound to plasma proteins.

Plasma protein binding is constant over the concentration range of 0.05 to 5 mcg/mL. Elimination: Metabolism: Lansoprazole is extensively metabolized in the liver. Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of lansoprazole).

These metabolites have very little or no antisecretory activity. Lansoprazole is thought to be transformed into two active species which inhibit acid secretion by blocking the proton pump [(H + , K + )-ATPase enzyme system] at the secretory surface of the gastric parietal cell. The two active species are not present in the systemic circulation.

The plasma elimination half-life of lansoprazole is less than two hours while the acid inhibitory effect lasts more than 24 hours. Therefore, the plasma elimination half-life of lansoprazole does not reflect its duration of suppression of gastric acid secretion. Excretion: Following single-dose oral administration of lansoprazole, virtually no unchanged lansoprazole was excreted in the urine.

In one study, after a single oral dose of 14 C-lansoprazole, approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the feces. This implies a significant biliary excretion of the lansoprazole metabolites. Specific Populations Pediatric Patient s: One to 17 years of age The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged one to 11 years and 12 to 17 years in two separate clinical studies.

In children aged one to 11 years, lansoprazole was dosed 15 mg daily for subjects weighing ≤30 kg and 30 mg daily for subjects weighing greater than 30 kg. Mean C max and AUC values observed on Day 5 of dosing were similar between the two dose groups and were not affected by weight or age within each weight-adjusted dose group used in the study. In adolescent subjects aged 12 to 17 years, subjects were randomized to receive lansoprazole at 15 or 30 mg daily.

Mean C max and AUC values of lansoprazole were not affected by body weight or age; and nearly dose-proportional increases in mean C max and AUC values were observed between the two dose groups in the study. Overall, lansoprazole pharmacokinetics in pediatric patients aged one to 17 years were similar to those observed in healthy adult subjects. Geriatric Patients: The clearance of lansoprazole is decreased in the elderly, with elimination half-life increased approximately 50 to 100%.

Because the mean half-life in the elderly remains between 1.9 to 2.9 hours, repeated once daily dosing does not result in accumulation of lansoprazole. Peak plasma levels were not increased in the elderly [see Use in Specific Populations ( 8.5 ) ]. Male and Female Patients: In a study comparing 12 male and six female human subjects who received lansoprazole, no sex-related differences were found in pharmacokinetic… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics Antisecretory Activity After oral administration, lansoprazole was shown to significantly decrease the basal acid output and significantly increase the mean gastric pH and percent of time the gastric pH was greater than three and greater than four. Lansoprazole also significantly reduced meal-stimulated gastric acid output and secretion volume, as well as pentagastrin-stimulated acid output. In patients with hypersecretion of acid, lansoprazole significantly reduced basal and pentagastrin-stimulated gastric acid secretion.

Lansoprazole inhibited the normal increases in secretion volume, acidity and acid output induced by insulin. The intragastric pH results of a five day, pharmacodynamic, crossover study of 15 and 30 mg of once daily lansoprazole are presented in Table 6. Table 6: Mean Antisecretory Effects After Single and Multiple Daily Lansoprazole Dosing Lansoprazole Parameter Baseline Value 15 mg 30 mg Day 1 Day 5 Day 1 Day 5 Mean 24 Hour pH 2.1 2.7* 4* 3.6 † 4.9 † Mean Nighttime pH 1.9 2.4 3* 2.6 3.8 † % Time Gastric pH>3 18 33* 59* 51 † 72 † % Time Gastric pH>4 12 22* 49* 41 † 66 † NOTE: An intragastric pH of greater than four reflects a reduction in gastric acid by 99%. * (p<0.05) vs baseline only. † (p<0.05) vs baseline and lansoprazole 15 mg.

After the initial dose in this study, increased gastric pH was seen within one to two hours with 30 mg of lansoprazole and two to three hours with 15 mg of lansoprazole. After multiple daily dosing, increased gastric pH was seen within the first hour post-dosing with 30 mg of lansoprazole and within one to two hours postdosing with 15 mg of lansoprazole. Acid suppression may enhance the effect of antimicrobials in eradicating Helicobacter pylori (H. pylori).

The percentage of time gastric pH was elevated above five and six was evaluated in a crossover study of lansoprazole given daily, twice daily and three times daily (Table 7). Table 7: Mean Antisecretory Effects After Five Days of Twice Daily and Three Times Daily Dosing Lansoprazole Parameter 30 mg daily 14 mg twice daily 30 mg twice daily 30 mg three times daily % Time Gastric pH>5 43 47 59* 77 + % Time Gastric pH>6 20 23 28 45 + * (p<0.05) vs lansoprazole 30 mg daily + (p<0.05) vs lansoprazole 30 mg daily, 15 and 30 mg twice daily.

The inhibition of gastric acid secretion as measured by intragastric pH gradually returned to normal over two to four days after multiple doses. There was no indication of rebound gastric acidity. Enterochromaffin-like (ECL) Cell Effects During lifetime exposure of rats with up to 150 mg/kg/day of lansoprazole dosed seven days per week, marked hypergastrinemia was observed followed by ECL cell proliferation and formation of carcinoid tumors, especially in female rats.

Gastric biopsy specimens from the body of the stomach from approximately 150 patients treated continuously with lansoprazole for at least one year did not show evidence of ECL cell effects similar to those seen in rat studies. Longer term data are needed to rule out the possibility of an increased risk of the development of gastric tumors in patients receiving long-term therapy with lansoprazole [see Nonclinical Toxicology ( 13.1 ) ]. Other Gastric Effects in Humans Lansoprazole did not significantly affect mucosal blood flow in the fundus of the stomach.

Due to the normal physiologic effect caused by the inhibition of gastric acid secretion, a decrease of about 17% in blood flow in the antrum, pylorus, and duodenal bulb was seen. Lansoprazole significantly slowed the gastric emptying of digestible solids. Lansoprazole increased serum pepsinogen levels and decreased pepsin activity under basal conditions and in response to meal stimulation or insulin injection.

As with other agents that elevate intragastric pH, increases in gastric pH were associated with increases in nitrate-reducing bacteria and elevation of nitrite concentration in gastric juice in patients with gastric ulcer. No significant increase in nit… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Duodenal Ulcer In a U.S. multicenter, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of lansoprazole once daily) study of 284 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after two and four weeks was significantly higher with all doses of lansoprazole than with placebo. There was no evidence of a greater or earlier response with the two higher doses compared with lansoprazole 15 mg. Based on this study and the second study described below, the recommended dose of lansoprazole in duodenal ulcer is 15 mg per day (Table 9).

Table 9: Duodenal Ulcer Healing Rates Placebo (N=72) Lansoprazole Week 15 mg daily (N=68) 30 mg daily (N=74) 60 mg daily (N=70) 2 42.4%* 35.6%* 39.1%* 11.3% 4 89.4%* 91.7%* 89.9%* 46.1% * (p≤0.001) vs placebo. Lansoprazole 15 mg was significantly more effective than placebo in relieving day and nighttime abdominal pain and in decreasing the amount of antacid taken per day. In a second U.S. multicenter study, also double-blind, placebo-controlled, dose-comparison (15 and 30 mg of lansoprazole once daily), and including a comparison with ranitidine, in 280 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after four weeks was significantly higher with both doses of lansoprazole than with placebo.

There was no evidence of a greater or earlier response with the higher dose of lansoprazole. Although the 15 mg dose of lansoprazole was superior to ranitidine at four weeks, the lack of significant difference at two weeks and the absence of a difference between 30 mg of lansoprazole and ranitidine leaves the comparative effectiveness of the two agents undetermined (Table 10) [see Indications and Usage ( 1.1 ) ]. Table 10: Duodenal Ulcer Healing Rates Lansoprazole Ranitidine Placebo (N=41) Week 15 mg daily (N=80) 30 mg daily (N=77) 300 mg h.s.

(N= 82) 2 35% 44.2% 30.5% 34.2% 4 92.3%* 80.3% † 70.5% † 47.5% *(p≤ 0.05) vs placebo and ranitidine. † (p≤ 0.05) vs placebo.

14.2Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the U.S. in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) evaluated the efficacy of lansoprazole in combination with amoxicillin and clarithromycin as triple 14 day therapy or in combination with amoxicillin as dual 14 day therapy for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of two different eradication regimens were established: Triple therapy: Lansoprazole 30 mg twice daily/amoxicillin 1 g twice daily/clarithromycin 500 mg twice daily Dual therapy: Lansoprazole 30 mg three times daily/amoxicillin 1 g three times daily All treatments were for 14 days.

H. pylori eradication was defined as two negative tests (culture and histology) at four to six weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies.

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. A randomized, double-blind clinical study performed in the U.S. in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) compared the efficacy of lansoprazole triple therapy for 10 and 14 days. This study established that the 10 day triple therapy was equivalent to the 14 day triple therapy in eradicating H. pylori (Tables 11 and 12) [see Indications and Usage ( 1.2 ) ].

Table 11: H. pylor i Eradication Rates – Triple Therapy (Lansoprazole/amoxicillin/clarithromycin) Percent of Patients Cured [95% Confidence Interval] (Number of patients) Study Duration Triple Therapy Evaluable Analysis* Triple Therapy Intent-to-Treat Analysis † M93-131 14 days 92 ‡ [80 to 97.7] (N=48) 86 ‡ [73.3 to 93.5] (N… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In two, 24 month carcinogenicity studies, Sprague-Dawley rats were treated with oral lansoprazole doses of 5 to 150 mg/kg/day, about one to 40 times the exposure on a body surface (mg/m 2 ) basis of a 50 kg person of average height [1.46 m 2 body surface area (BSA)] given the recommended human dose of 30 mg/day. Lansoprazole produced dose-related gastric enterochromaffin-like (ECL) cell hyperplasia and ECL cell carcinoids in both male and female rats. It also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes.

In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (four to 40 times the recommended human dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat. In a 24 month carcinogenicity study, CD-1 mice were treated with oral lansoprazole doses of 15 to 600 mg/kg/day, two to 80 times the recommended human dose based on BSA.

Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg/kg/day (40 to 80 times the recommended human dose based on BSA) and female mice treated with 150 to 600 mg/kg/day (20 to 80 times the recommended human dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice.

Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human dose based on BSA). A 26 week p53 (+/-) transgenic mouse carcinogenicity study was not positive. Lansoprazole was positive in the Ames test and the in vitro human lymphocyte chromosomal aberration assay.Lansoprazole was not genotoxic in the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test, or the rat bone marrow cell chromosomal aberration test.

Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In two, 24 month carcinogenicity studies, Sprague-Dawley rats were treated with oral lansoprazole doses of 5 to 150 mg/kg/day, about one to 40 times the exposure on a body surface (mg/m 2 ) basis of a 50 kg person of average height [1.46 m 2 body surface area (BSA)] given the recommended human dose of 30 mg/day. Lansoprazole produced dose-related gastric enterochromaffin-like (ECL) cell hyperplasia and ECL cell carcinoids in both male and female rats. It also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes.

In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (four to 40 times the recommended human dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat. In a 24 month carcinogenicity study, CD-1 mice were treated with oral lansoprazole doses of 15 to 600 mg/kg/day, two to 80 times the recommended human dose based on BSA.

Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg/kg/day (40 to 80 times the recommended human dose based on BSA) and female mice treated with 150 to 600 mg/kg/day (20 to 80 times the recommended human dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice.

Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human dose based on BSA). A 26 week p53 (+/-) transgenic mouse carcinogenicity study was not positive. Lansoprazole was positive in the Ames test and the in vitro human lymphocyte chromosomal aberration assay.Lansoprazole was not genotoxic in the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test, or the rat bone marrow cell chromosomal aberration test.

Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE Lansoprazole Delayed-Release Orally Disintegrating Tablets (lan soe' pra zole) Important: • Take lansoprazole delayed-release orally disintegrating tablets before meals. • Do not crush or chew lansoprazole delayed-release orally disintegrating tablets. • Lansoprazole delayed-release orally disintegrating tablets should only be used with the foods and juices listed below. Lansoprazole Delayed-Release Orally Disintegrating Tablets 1. Do not chew, crush, cut or break the tablets.

2. Put the tablet on the tongue and let it dissolve, with or without water. 3.

Swallow after the tablet dissolves. 4. The tablet usually dissolves in less than 1 minute.

For patients who have trouble swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be given as follows: Giving lansoprazole delayed-release orally disintegrating tablets with water using an oral syringe: 1. Put a 15 mg tablet in an oral syringe and draw up 4 mL of water into the oral syringe, or put a 30 mg tablet in an oral syringe and draw up 10 mL of water into the oral syringe. 2.

Gently shake the oral syringe to mix the tablet and the water. 3. After the tablet is mixed in the water, place the tip of the oral syringe in the mouth.

Give the medicine within 15 minutes of mixing. Do not save the tablet and water mixture for later use. 4.

Refill the oral syringe with about 2 mL of water for the 15 mg tablet or 5 mL of water for the 30 mg tablet, and shake gently. Place the tip of the oral syringe in the mouth and give the medicine that is left in the syringe. Giving lansoprazole delayed-release orally disintegrating tablets with water through a nasogastric tube (NG tube) size 8 French or larger: 1.

Put a 15 mg tablet in a catheter-tip syringe and draw up 4 mL of water, or put a 30 mg tablet in a catheter-tip syringe and draw up 10 mL of water. 2. Gently shake the catheter-tip syringe to mix the tablet and the water.

3. Connect the catheter-tip syringe to the NG tube. 4.

Give the mixture right away through the NG tube that goes into the stomach. Give the medicine within 15 minutes of mixing. Do not save the granule and water mixture for later use.

5. Refill the catheter-tip syringe with about 5 mL of water and shake gently. Flush the NG tube with the water.

How should I store lansoprazole delayed-release orally disintegrating tablets? • Store lansoprazole delayed-release orally disintegrating tablets at room temperature between 20° to 25° C (68° to 77° F) Keep lansoprazole delayed-release orally disintegrating tablets and all medicines out of the reach of children. This Instruction for Use has been approved by the U.S. Food and Drug Administration.

All other trademark names are the property of their respective owners. Rx only Distributor: Dr. Reddy’s Laboratories Inc., Princeton NJ 08540 Made in India Revised: 07/2023

📄 Package Label / Principal Display Panel 24 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lansoprazole Delayed- Release Orally Disintsegrating Tablets, 15 mg Carton Label

Lansoprazole Delayed- Release Orally Disintsegrating Tablets, 30 mg- Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
158
Units reimbursed last 4 qtrs
5.8K
Gross reimbursed last 4 qtrs
$16.4K
Avg / prescription
$103.67
Avg / unit
$2.8379
Latest quarter Q4 2025
19Rx
Medicaid pays / ea
$2.8379
gross reimbursed
vs
NADAC / ea
$2.2558
acquisition cost
=
Spread
+$0.5821
+26% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
91% FFS
Fee-for-service · 143 Rx Managed care · 15 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 564 units · 4.5 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,293 units · 5.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 2,915 units · 57.1 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.557.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Alabama 57.1 /100k
2 California 5.9 /100k
3 Illinois 4.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lansoprazole — the program that covers self-administered drugs. 13 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lansoprazole. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.11M
Claims incl. refills
326.1K
Beneficiaries
241.2K
Spend / beneficiary
$46.07
Spend / claim
$34.08
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Dr.Reddys Laboratories Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 43598-0559-05 · Dr.Reddys 43598-0566-01 · Dr.Reddy's →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.