Home › NDC Lookup › Ingredients › Lansoprazole › 31722-0571-01
Lansoprazole 30 mg Capsule, Delayed Release, 100-count — NDC 31722-0571-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lansoprazole 30 mg Capsule, Delayed Release, 100-count — NDC 31722-571-01 (Billing 31722-0571-01)

by Camber Pharmaceuticals, Inc. · 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of 100 capsules of Lansoprazole 30 mg Capsule, Delayed Release from Camber Pharmaceuticals, Inc., marketed since May 2020 and currently FDA-listed.

NDC 31722-0571-01
🏷️ FDA NDC (as labeled) 31722-571-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.4438/unit — full pricing hub ↓
Product page 31722-0571-90 Also comes in: 30 capsules 31722-571-30 90 capsules 31722-571-90 500 capsules 31722-571-05 1000 capsules 31722-571-10
Rx only Generic On market Non-controlled ⇄ 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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 31722-571-01
Product NDC 31722-571
11-digit billing NDC 31722057101
RxCUI 311277, 596843
UNII 0K5C5T2QPG
UPC 0331722571302, 0331722570305
Application # ANDA203083
SPL Set ID 03b7dceb-2128-4324-b068-7f76a2d9887e
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 On market
FDA listing status Listed (active directory)
Marketing start 2020-05-18
Route ORAL
Dosage form CAPSULE, 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 49270040006520
GPI class Lansoprazole
GCN Seq No 030107
GCN 01698
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 CAPSULE
FDB brand name Lansoprazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 030107
  • GCN: 01698
  • GPI-14 (Medi-Span): 49270040006520
  • HICL (First Databank): 008993
  • AHFS class code: 56:28.36.00
  • RxCUI (RxNorm): 311277
Why two NDCs? The FDA registers this code as 31722-571-01 — 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 → 31722-0571-01. 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 CAPSULE 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.4438 $44.38 / 100 capsules
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 Per unit Per pack Marketing startMarketing endStatus
31722-0571-01 You're viewing this 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE — — 2020-05-18 — Active
31722-0571-05 31722-571-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.1061 / ea $53.05 2020-05-18 — Active
31722-0571-10 31722-571-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE — — 2020-05-18 — Active
31722-0571-30 31722-571-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.1061 / ea $3.18 2020-05-18 — Active
31722-0571-90 31722-571-90 Main listing 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.1061 / ea $9.55 2020-05-18 — Active

You're viewing one of 5 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 90 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule, delayed release in 1 bottle.
How does this package differ from NDC 31722-0571-30?
Both are Lansoprazole 30 mg Capsule, Delayed Release — the drug itself is identical. This page's package is the 100-count one, while NDC 31722-0571-30 is the 30 capsules package.
What NDC number is used to bill for this package of Lansoprazole 30 mg Capsule, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lansoprazole 30 mg 00093-7351-56 Teva 30 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 00378-8030-05 Mylan 500 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 00904-6662-45 Major 1 capsule $0.106 AB Availability likely —
Lansoprazole 30 mg 51079-0121-08 Mylan 1 capsule $0.106 AB Availability likely —
Lansoprazole 30 mg 60687-0123-01 American 1 capsule $0.106 AB Availability likely —
Lansoprazole 30 mg 68001-0112-03 BluePoint 500 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 70700-0263-05 Xiromed 500 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 82009-0039-05 Quallent 500 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 27241-0020-03 Ajanta 30 capsules — — FDA listed —
Lansoprazole 30 mgthis 31722-0571-01 Camber 100 capsules — AB FDA listed —
Lansoprazole 30 mg 33342-0311-07 Macleods 30 capsules — — FDA listed —
Lansoprazole 30 mg 48433-0051-08 Safecor 1 capsule — AB FDA listed —
Lansoprazole 30 mg 50090-5180-00 A-S 30 capsules — AB FDA listed —
Lansoprazole 30 mg 50090-6154-00 A-S 30 capsules — AB FDA listed —
Lansoprazole 30 mg 50090-6830-00 A-S 90 capsules — AB FDA listed —
Lansoprazole 30 mg 50090-7651-00 A-S 90 capsules — AB FDA listed —
Lansoprazole 30 mg 51407-0324-01 Golden 100 capsules — AB FDA listed —
lansoprazole 30 mg 55111-0399-01 Dr. 100 capsules — — FDA listed —
Lansoprazole 30 mg 63187-0152-30 Proficient 30 capsules — AB FDA listed —
Lansoprazole 30 mg 63187-0510-30 Proficient 30 capsules — AB FDA listed —
Lansoprazole 30 mg 63629-2340-01 Bryant 500 capsules — AB FDA listed —
Lansoprazole 30 mg 63629-2341-01 Bryant 90 capsules — AB FDA listed —
Lansoprazole 30 mg 63629-2342-01 Bryant 30 capsules — AB FDA listed —
Prevacid 30 mg 64764-0046-06 Takeda 4 capsules — AB FDA listed —
Lansoprazole 30 mg 67877-0275-30 Ascend 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68071-3572-04 NuCare 14 capsules — AB FDA listed —
Lansoprazole 30 mg 68071-3585-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68071-3870-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68071-5119-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68788-7742-01 Preferred 14 capsules — AB FDA listed —
Lansoprazole 30 mg 68788-8621-01 Preferred 14 capsules — AB FDA listed —
Lansoprazole 30 mg 70756-0807-30 Lifestar 30 capsules — AB FDA listed —
Lansoprazole 30 mg 71335-1425-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 30 mg 71335-1820-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 30 mg 72162-1976-03 Bryant 30 capsules — AB FDA listed —
Lansoprazole DR 30 mg 72189-0370-90 Direct_Rx 90 capsules — AB Discontinued —
Lansoprazole 30 mg 76420-0621-90 Asclemed 90 capsules — AB FDA listed —
Lansoprazole DR 30 mg 80425-0174-01 Advanced 30 capsules — AB FDA listed —
Lansoprazole 30 mg 82461-0713-30 Medcore 30 capsules — AB FDA listed —
Lansoprazole 30 mg 67296-2270-03 Redpharm 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68788-4141-03 Preferred 30 capsules — 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

🏛️
2020
On the market since
May 2020
📍
2026
Currently FDA-listed
6 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.

What it looks like

Color Pink / Green / Black
ShapeCapsule
ImprintH;167
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • UNII 0E53J927NA
    Magnesium carbonate is a mineral powder used in medicines as a filler to add bulk and as a buffer to help regulate acidity in the formulation.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII MB5IUD6JUA
    Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

17 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerCamber Pharmaceuticals, Inc.
Application holderHETERO LABS LTD UNIT III
FDA applicationANDA203083 (ANDA)
Labeler code31722
First marketedMay 2020
Product typeHuman Prescription Drug
Portfolio603 products on file
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. 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
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Lansoprazole delayed-release capsules are proton pump inhibitor (PPIs) 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 non-steroidal 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 capsules 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 capsules /amoxicillin/clarithromycin Lansoprazole delayed-release capsules 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 capsules /amoxicillin Lansoprazole delayed-release capsules 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage: •See full prescribing information for complete dosing information for lansoprazole delayed-release capsules 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 capsules •Should be swallowed whole. •See full prescribing information for alternative administration options.

2.1Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment Maintenance of Healed 15 mg 15 mg Once daily for 4 weeks Once daily Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed- release capsules Amoxicillin Clarithromycin Dual Therapy: Lansoprazole delayed- release capsules Amoxicillin 30 mg 1 gram 500 mg 30 mg 1 gram Twice daily for 10 or 14 days Twice daily for 10 or 14 days Twice daily for 10 or 14 days Three times daily for 14 days 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 Risk Reduction 30 mg 15 mg Once daily for 8 weeks † Once daily for up to 12 weeks † Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD Short-Term Treatment of Erosive Esophagitis 15 mg 30 mg Once daily for up to 8 weeks 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 capsules 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 capsules 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 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 delayed-release capsules were not administered beyond 12 weeks in 1 to 11 year olds. It is not known if lansoprazole delayed-release capsules are 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 Specific Populations ( 8.6 )] .

2.4Important Administration Information • Take lansoprazole delayed-release capsules before meals. • Do not crush or chew lansoprazole delayed-release capsules. • Take lansoprazole delayed-release capsules at least 30 minutes prior to…

💊 Dosage Forms and Strengths 73 words ▾

3 DOSAGE FORMS AND STRENGTHS • 15 mg capsules are pink/green colored size "3" hard gelatin capsules imprinted with 'H' on cap and '166' on body filled with white to off white pellets. • 30 mg capsules are pink/black colored size "1" hard gelatin capsules imprinted with 'H' on cap and '167' on body filled with white to off white pellets. • Delayed-release capsules : 15 mg and 30 mg. ( 3 )

⛔ Contraindications 119 words ▾

4 CONTRAINDICATIONS • Lansoprazole delayed-release capsules are contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions ( 6 )] . • Proton Pump Inhibitors (PPIs), including lansoprazole delayed-release capsules, 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 capsules, refer to the Contraindications section of their prescribing information. • Contraindicated in patients with known severe hypersensitivity to any component of the lansoprazole delayed-release capsules formulation.

( 4 ) • Patients receiving rilpivirine-containing products. ( 4 , 7 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Gastric Malignancy : In adults, symptomatic response with lansoprazole 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 ) • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue lansoprazole and refer to specialist for evaluation.

( 5.5 ) • Cyanocobalamin (Vitamin B12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.6 ) • Hypomagnesemia: Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. ( 5.7 ) • 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.

( 5.8 , 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 delayed-release capsule ( 5.9 , 7 ) • Fundic Gland Polyps: Risk increases with long-term use, especially beyond 1 year. Use the shortest duration of therapy.

( 5.11 )

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with lansoprazole 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 Interstitial Nephritis Acute interstitial nephritis has been observed in patients taking PPIs including lansoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue lansoprazole if acute interstitial nephritis develops [see Contraindications ( 4 )] .

5.3Clostridium difficile-Associated Diarrhea Published observational studies suggest that PPI therapy like lansoprazole 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 )] . Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with lansoprazole, refer to Warnings and Precautions section of their prescribing information.

5.4Bone Fracture Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration ( 2 ), Adverse Reactions ( 6.2 )] .

5.5 Cutaneous and Systemic Lupus Erythemato…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Acute Interstitial 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 )] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.5 )] • Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions ( 5.6 )] • Hypomagnesemia [see Warnings and Precautions ( 5.7 )] • Fundic Gland Polyps [see Warnings and Precautions ( 5.11 )] Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 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-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, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, ga…

🔄 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 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 Co-Administered with Lansoprazole 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 antiviral effect and promote the development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with lansoprazole may increase toxicity of the antiretroviral drugs. • There are other antiretroviral drugs which do not result in clinically relevant interactions with lansoprazole.

Intervention: Rilpivirine-containing products: Concomitant use with lansoprazole is contraindicated [see Contraindications ( 4 )] . See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information.

Nelfinavir: Avoid concomitant use with lansoprazole. 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 ( 5.8 )] . Intervention: A temporary withdrawal of lansoprazole may 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 is 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): Co-administration 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 and MMF. Use lansoprazole with caution in transplant patients receiving and MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.

Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration…

👥 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: Lansoprazole is not effective in patients with symptomatic GERD 1 month to less than 1 year of age and nonclinical studies have demonstrated adverse effects in juvenile rats. ( 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 a 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 is 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 decrease…

🤰 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 a 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 is 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/day on postnatal Day 21. Femur weight was still decre…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use 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. 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.

The safety and effectiveness of lansoprazole have been established in pediatric patients one 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 one 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 (see Juvenile Animal Toxicity Data). 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 multi-center, 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., non-pharmacologic 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 to 11 years of age In an uncontrolled, open-label, U.S. multi-center study, 66 pediatric patients (one 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 erosive esophagitis patients were healed at eight weeks and 100% of patients were healed at 12 weeks by endoscopy (Table 4). Table…

🧓 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 102 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 mg 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 * 4.0 * 3.6 † 4.9 † Mean Nighttime pH 1.9 2.4 3.0 * 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 post-dosing 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 15 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 mg twice daily 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…

🧬 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 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Lansoprazole delayed-release capsules USP, 15 mg are pink/green colored size '3' hard gelatin capsules imprinted with 'H' on cap and '166' on body filled with white to off white pellets. They are available as follows: Bottles of 30 capsules (NDC 31722-570-30) Bottles of 90 capsules (NDC 31722-570-90) Bottles of 100 capsules (NDC 31722-570-01) Bottles of 500 capsules (NDC 31722-570-05) Bottles of 1000 capsules (NDC 31722-570-10) Lansoprazole delayed-release capsules USP, 30 mg are pink/black colored size '1' hard gelatin capsules imprinted with 'H' on cap and '167' on body filled with white to off white pellets.

They are available as follows: Bottles of 30 capsules (NDC 31722-571-30) Bottles of 90 capsules (NDC 31722-571-90) Bottles of 100 capsules (NDC 31722-571-01) Bottles of 500 capsules (NDC 31722-571-05) Bottles of 1000 capsules (NDC 31722-571-10) 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 capsules, USP is lansoprazole, 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 369.36. Lansoprazole has the following structure: Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C.

Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. The rate of degradation of the compound in aqueous solution increases with decreasing pH. Lansoprazole is supplied in delayed-release capsules for oral administration.

Lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate.

The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No.

40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3.

The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide. Lansoprazolestructure

💬 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 Interstitial Nephritis To call their healthcare provider if they experience signs and/or symptoms associated with acute interstitial 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 )] . 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 ( 5.5 )] . 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 for longer than three years [see Warnings and Precautions ( 5.6 )] .

Hypomagnesemia To report any clinical symptoms that may be associated with hypomagnesemia to their healthcare provider, if they have been receiving lansoprazole for at least three months [see Warnings and Precautions ( 5.7 )] . 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 ( 5.9 )] . 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 capsules should be taken before eating. • Do not crush or chew lansoprazole delayed-release capsules. • Take lansoprazole delayed-release capsules at least 30 minutes prior to sucralfate. Lansoprazole Delayed-Release Capsules • Swallow whole; do not chew. • For patients who have difficulty swallowing capsules: o Lansoprazole delayed-release capsules can be opened and sprinkled on applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears o Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice o Alternatively, lansoprazole delayed-release capsules can be administered with apple juice via nasogastric tube o See the Instructions for Use for a description of all preparation and administration instructions Manufactured for: Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854 By: HETERO TM HETERO LABS LIMITED Jeedimetla, Hyderabad - 500 055, India Revised: 05/2020 camber

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
90 capsules31722-0571-90 7,443 Rx · $104,745
500 capsules31722-0571-05 3,464 Rx · $47,378
100 capsules this page31722-0571-01 No Medicaid data
1000 capsules31722-0571-10 No Medicaid data
30 capsules31722-0571-30 No Medicaid data
Drug total (last 4 qtrs): 10,907 Rx · 539,358 units · $152,124 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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
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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Camber Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 30 capsules (31722-0571-30), 90 capsules (31722-0571-90), 500 capsules (31722-0571-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Camber Pharmaceuticals, 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.
← 31722-0570-01 · Camber 31722-0574-47 · Camber →
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.