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Pantoprazole Sodium 40 mg Tablet, Delayed Release, 90-count — NDC 68071-4864-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pantoprazole Sodium 40 mg Tablet, Delayed Release, 90-count — NDC 68071-4864-9 (Billing 68071-4864-09)

by NuCare Pharmaceuticals,Inc. · 90 TABLET, DELAYED RELEASE in 1 BOTTLE

This is a package of 90 tablets of Pantoprazole Sodium 40 mg Tablet, Delayed Release from NuCare Pharmaceuticals,Inc., marketed since Sep 2014 and currently FDA-listed. It is this product's only package size.

NDC 68071-4864-09
🏷️ FDA NDC (as labeled) 68071-4864-9 billing pads the package segment with a zero
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

⚠️
Other active recalls for Pantoprazole (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 26, 2026 — Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." (Hetero Labs Limited (Unit V)) · FDA recall D-0484-2026
Class II · Mar 14, 2023 — CGMP Deviations: Discoloration (Hetero USA Inc) · FDA recall D-0530-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68071-4864-9
Product NDC 68071-4864
11-digit billing NDC 68071486409
RxCUI 314200
UNII 6871619Q5X
UPC 0368071486490
Application # ANDA202882
SPL Set ID 8748a588-a1e5-9dfc-e053-2a95a90a846c
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-10
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance PANTOPRAZOLE SODIUM
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 314200
Why two NDCs? The FDA registers this code as 68071-4864-9 — a 5-4-1 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 package segment → 68071-4864-09. 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

📗 Our plain-language guide HelloPharmacist
  • It lowers stomach acid. It is used to heal and keep healed the irritation of the esophagus caused by GERD, and to treat conditions where the stomach makes too much acid, like Zolli...
  • Tablets can be taken with or without meals. If you use the granule suspension, take it about 30 minutes before a meal. Follow your prescriber’s schedule and the directions on your...
  • The most common are headache, diarrhea, nausea, belly pain, gas, and dizziness. Call your doctor for a severe rash, diarrhea that will not clear up, muscle spasms or an irregular h...
  • Some people need it long term, but your prescriber should use the lowest dose for the shortest time that works. Long-term use has been linked to fractures, low vitamin B-12, low ma...
📖 Read our full Pantoprazole guide →
9
Nutrient depletion considerations

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

🧪 Full Pantoprazole 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 $0.1131 $10.18 / 90 tablets
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
68071-4864-09 You're viewing this Main listing 90 TABLET, DELAYED RELEASE in 1 BOTTLE 2019-04-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pantoprazole Sodium 40 mg 00378-6689-10 Mylan 1000 tablets $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 00904-6870-45 Major 1 tablet $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 13668-0429-05 Torrent 500 tablets $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 31722-0713-10 Camber 1000 tablets $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 35573-0428-80 Burel 10 tablets $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 50268-0639-15 AvPAK 1 tablet $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 51079-0051-20 Mylan 1 tablet $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 60687-0736-01 American 1 tablet $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 62135-0534-08 Chartwell 450 tablets $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 62175-0617-43 Lannett 1000 tablets $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 64980-0677-09 Rising 90 tablets $0.036 AB Availability likely —
pantoprazole sodium 40 mg 70010-0191-09 Granules 90 tablets $0.036 AB Availability likely —
Pantoprazole sodium delayed-release 40 mg 70756-0019-12 Lifestar 1000 tablets $0.036 AB Availability likely —
Pantoprazole 40 mg 72603-0178-01 NorthStar 90 tablets $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 72603-0746-01 NorthStar 500 tablets $0.036 AB Availability likely —
Pantoprazole Sodium 40 mg 82009-0011-90 Quallent 90 tablets $0.036 AB Availability likely —
Protonix Delayed-Release 40 mg 00008-0841-81 Wyeth 90 tablets $14.235 AB Availability likely —
Pantoprazole Sodium 40 mg 00615-7629-05 NCS 15 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 00904-6474-45 Major 1 tablet — AB Discontinued —
Pantoprazole Sodium 40 mg 42708-0104-30 QPharma 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 42708-0180-30 QPharma 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 42708-0185-30 QPharma 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 43353-0027-30 Aphena 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 48433-0081-20 Safecor 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 50090-5378-00 A-S 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 50090-5379-00 A-S 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 50090-5794-00 A-S 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 50090-7512-00 A-S 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 51407-0613-10 Golden 1000 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 51655-0797-52 Northwind 30 tablets — AB FDA listed —
Pantoprazole 40 mg 55111-0333-01 Dr. 100 tablets — — FDA listed —
Pantoprazole Sodium 40 mg 55154-4165-00 Cardinal 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 55154-4382-00 Cardinal 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 55154-7634-00 Cardinal 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 60760-0679-30 St. 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 63187-0654-30 Proficient 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 63187-0938-30 Proficient 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 63187-0974-30 Proficient 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 65162-0637-03 Amneal 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 65862-0560-10 Aurobindo 10 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 67046-0536-03 Coupler 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-1963-03 NuCare 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-2215-03 NuCare 30 tablets — AB FDA listed —
Pantoprazole 40 mg 68071-3524-03 NuCare 30 tablets — AB FDA listed —
Pantoprazole 40 mg 68071-3995-09 NuCare 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mgthis 68071-4864-09 NuCare 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-4895-09 NuCare 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68071-4917-04 NuCare 14 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 68788-8644-01 Preferred 100 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 70518-0860-00 REMEDYREPACK 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 70518-1298-01 REMEDYREPACK 1 tablet — AB FDA listed —
Pantoprazole Sodium 40 mg 71335-0310-01 Bryant 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 71335-0551-01 Bryant 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 71335-1429-01 Bryant 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 71610-0653-30 Aphena 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 72162-1746-03 Bryant 30 tablets — AB FDA listed —
Pantoprazole Sodium DR 40 mg 72189-0514-90 Direct_Rx 90 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 72789-0086-30 PD-Rx 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 72789-0268-30 PD-Rx 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 72865-0230-10 XLCare 1000 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 76420-0669-10 Asclemed 10 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 76420-0674-01 Asclemed 100 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 76420-0806-10 Asclemed 10 tablets — AB FDA listed —
Pantoprazole Sodium DR 40 mg 80425-0133-01 Advanced 30 tablets — AB FDA listed —
Pantoprazole Sodium DR 40 mg 80425-0162-01 Advanced 30 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 85534-0028-00 HAWAII 10 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 85766-0225-01 Sportpharm 100 tablets — AB FDA listed —
Pantoprazole Sodium 40 mg 50268-0727-10 AvPAK 1 tablet — 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

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 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.

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

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 74G4R6TH13
    A synthetic polymer made by combining two plastic-like chemicals. It forms a coating on tablets or capsules that dissolves at a specific point in the digestive tract, controlling where and when the medicine releases.
  • 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

15 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

LabelerNuCare Pharmaceuticals,Inc.
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA202882 (ANDA)
Labeler code68071
First marketedSep 2014
Product typeHuman Prescription Drug
Portfolio1,015 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. 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.
🚨 Boxed Warning 🎯 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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 2 words ▾

BOXED WARNING

🎯 Indications and Usage 211 words ▾

1 INDICATIONS & USAGE Pantoprazole Sodium Delayed-Release Tablets are indicated for: Pantoprazole sodium delayed-release tablet is a proton pump inhibitor (PPI) indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) • Maintenance of Healing of Erosive Esophagitis ( 1.2 ) • Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 1.3 )

1.1Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole Sodium Delayed-Release Tablet is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

1.2Maintenance of Healing of Erosive Esophagitis Pantoprazole Sodium Delayed-Release Tablets are indicated for maintenance of healing EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.

1.3Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole Sodium Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE & ADMINISTRATION Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD ( 2.1 ) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis ( 2.1 ) Adults 40 mg Once Daily* Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 2.1 ) Adults 40 mg Twice Daily *Controlled studies did not extend beyond 12 months See full prescribing information for administration instructions

2.1Recommended Dosing Schedule Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily*** Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily ** * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated.

Doses up to 240 mg daily have been administered. *** Controlled studies did not extend beyond 12 months

2.2Administration Instructions Directions for method of administration for each dosage form are presented in Table 2. Tab le 2: Administration Instructions Formulation Route Instructions* Delayed-Release Tablets Oral Swallowed whole, with or without food * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed. Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach.

If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS & STRENGTHS • 20 mg, yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted “H125” on one side with black ink and plain on the other side. • 40 mg, yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted “H126” on one side with black ink and plain on the other side. •Delayed-Release Tablets, 20 mg and 40 mg ( 3 )

⛔ Contraindications 87 words ▾

4 CONTRAINDICATIONS •Pantoprazole Sodium Delayed-Release Tablets are contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6)]. • Proton pump inhibitors (PPIs), including pantoprazole sodium delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions ( 7) ]. • Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles ( 4) • Patients receiving rilpivirine-containing products (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Gastric Malignancy: In adults, Symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagonostic testing. ( 5.1 ) • Acute interstitial nephritis :Observed in patients taking PPIs.

( 5.2 ) • Clostridium difficile-associated diarrhea: PPI therapy may be associated with increased risk .( 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 pantoprazole sodium delayed-release tablet and refer to specialist for evalution. ( 5.5 ) • Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.

( 5.6 ) • Hypomagnesemia: Reported rarely with prolonged treatment with PPIs ( 5.7 )

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagonostic 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 pantoprazole sodium delayed-release tablets. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue pantoprazole sodium delayed-release tablets if acute interstitial nephritis develops [see Contraindications (4)].

5.3Clostridium difficile- Associated Diarrhea Published observational studies suggest that PPI therapy like pantoprazole sodium may be associated with an increased risk of Clostridium difficile associated diarrhea, 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.

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) and Adverse Reactions ( 6.2)].

5.5Cutaneous and Systemic Lupus Erythematosus lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium. These events have occurred as both new onset of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE. common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants .

Generally, histological findings were observed without organ involvement. lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically within days to years after initiating treatment primarily in patients ranging from young adults to the elderly.

The majority of patients presented with rash; however, arthralgia and cytopenia reported. administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in pati… [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 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 B-12) Deficiency [see Warnings and Precautions (5.6)] • Hypomagnesemia [see Warnings and Precautions (5.7)] Most common adverse reactions are: • For adult use (>2%) headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.

( 6.1 ) • For pediatric use (>4%) URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience The adverse reaction profiles for Pantoprazole Sodium For Delayed-Release Oral Suspension and Pantoprazole Sodium Delayed-Release Tablets are similar. 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. Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole sodium (20 mg or 40 mg), 299 patients on an H 2 -receptor antagonist, 46 patients on another PPI, and 82 patients on placebo.

The most frequently occurring adverse reactions are listed in Table 3. Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Pantoprazole sodium (n=1473) % Comparators (n=345) % Placebo (n=82) % Headache 12.2 12.8

8.5Diarrhea 8.8 9.6

4.9Nausea 7 5.2

9.8Abdominal pain 6.2 4.1

6.1Vomiting Flatulence 4.3 3.9 3.5 2.9 2.4

3.7Dizziness 3 2.9

1.2Arthralgia 2.8 1.4

1.2Additional adverse reactions that were reported for pantoprazole sodium in clinical trials with a frequency of ≤ 2% are listed below by body system: Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia, thrombocytopenia Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Pediatric Patients Safety of pantoprazole sodium in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials.

Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to pantoprazole sodium are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (> 4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.

For safety information in patients less than 1 year of age see Use in Specific Populations ( 8.4 ) . Additional adverse reactions that were reported for pantoprazole sodium in pediatric patients in clinical trials with a frequency of ≤ 4% are listed below by body system: Body as a Whole: allergic reaction, facial edema Gastrointestinal: constipation, flatulence, nausea Metabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase) Musculoskeletal: arthralgia, myalgia Nervous: dizziness, vertigo Skin and Appendages: urticaria The following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trial… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium delayed-release tablets and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 4: Clinically relevant Interactions Affecting Drugs Co-Administered with pantoprazole sodium and Interaction 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 pantoprazole sodium may reduce antiviral effect and promote the development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole sodium may increase toxicity . • There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole sodium.

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

See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals: See prescribing information for specific antiretroviral drugs.

Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole sodium, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain the target INR range.

Methotrexate Clinical Impact: Concomitant use of pantoprazole sodium 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 pantoprazole sodium may be considered in some patients receiving high-dose methotrexate.

Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole) Clinical Impact: Pantoprazole sodium can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium 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 Pantoprazole Sodium for Injection and MMF. Use pantoprazole sodium with caution in transplant patients receiving MMF [see Clinical Pharmacology ( 12.3 )] . See the prescribing information for other drugs dependent on gastric pH for absorption.

False Positive Urine Tests for THC Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs, including pantoprazole sodium [see Warnings and Precautions ( 5.9)] . Intervention: An alternative confirmatory method should be considered to verify positive results. See full prescribing information for a list of clinically important drug interactions (7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Teratogenic Effects Pregnancy Category C Reproduction studies have been performed in rats at oral pantoprazole doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole.

A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. On postnatal day (PND 4) through PND 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in humans at a dose of 40 mg).

There were no drug-related findings in maternal animals. During the preweaning dosing phase (PND 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (AUC) in humans receiving the 40 mg dose) and higher doses. On PND 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

The femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. Changes in bone parameters were partially reversible following a recovery period, with findings on PND 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

There are no adequate and well-controlled studies in pregnant women. Advise pregnant women of the potential risk of fetal harm. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3Nursing Mothers Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium. The clinical relevance of this finding is not known.

Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

8.4Pediatric Use The safety and effectiveness of pantoprazole sodium for short-term treatment (up to eight weeks) of erosive esophagitis (EE) associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age. In addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available.

Therefore, pantoprazole sodium is indicated for the short-term treatment of EE associated with GERD for patients 5 years and older. The safety and effectiveness of pantoprazole sodium for pediatric uses other than EE have not been established. 1 year throug… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Teratogenic Effects Pregnancy Category C Reproduction studies have been performed in rats at oral pantoprazole doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole.

A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. On postnatal day (PND 4) through PND 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in humans at a dose of 40 mg).

There were no drug-related findings in maternal animals. During the preweaning dosing phase (PND 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (AUC) in humans receiving the 40 mg dose) and higher doses. On PND 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

The femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. Changes in bone parameters were partially reversible following a recovery period, with findings on PND 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

There are no adequate and well-controlled studies in pregnant women. Advise pregnant women of the potential risk of fetal harm. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of pantoprazole sodium for short-term treatment (up to eight weeks) of erosive esophagitis (EE) associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age. In addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available.

Therefore, pantoprazole sodium is indicated for the short-term treatment of EE associated with GERD for patients 5 years and older. The safety and effectiveness of pantoprazole sodium for pediatric uses other than EE have not been established. 1 year through 16 years of age Use of pantoprazole sodium in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of pantoprazole sodium for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see Clinical Studies ( 14.1 ), and Clinical Pharmacology ( 12.3) ] .

Safety of pantoprazole sodium in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel - treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years). The children ages 1 year to 5 years with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of pantoprazole sodium (approximating 0.6 mg/kg or 1.2 mg/kg).

All 4 of these patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. Because EE is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic GERD were also included in these studies. Patients were treated with a range of doses of pantoprazole sodium once daily for 8 weeks.

For safety findings see Adverse Reactions (6.1) . Because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of pantoprazole sodium for symptomatic GERD in the pediatric population. The effectiveness of pantoprazole sodium for treating symptomatic GERD in pediatric patients has not been established.

Although the data from the clinical trials support use of pantoprazole sodium for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [see Dosage and Administration ( 2 )] . In a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of

2.4L/h. Following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg), the plasma concentrations of pantoprazole were highly variable and the median time to peak plasma concentration was 3 to 6 hours. The estimated AUC for patients 1 to 5 years old was 37% higher than for adults receiving a single 40 mg tablet, with a geometric mean AUC value of 6.8 mcg•hr/mL.

Neonates to less than one year of age Pantoprazole sodium was not found to be effective in a multicenter, randomized, double-blind, placebo- controlled, treatment-withdrawal study of 129 pediatric patients 1 through 11 months of age. Patients were enrolled if they had symptomatic GERD based on medical history and had not responded to non-pharmacologic interventions for GERD for two weeks. Patients received pantoprazole sodium daily for four weeks in an open-label phase, then patients were randomized in equal proportion to receive pantoprazole sodium treatment o… [Excerpted — this section continues on DailyMed.]

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use In short-term US clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥ 65 years old) treated with pantoprazole sodium were similar to those found in patients under the age of 65. The incidence rates of adverse reactions and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.

🆘 Overdosage 90 words ▾

10 OVERDOSAGE Experience in patients taking very high doses of pantoprazole sodium (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of pantoprazole sodium. Pantoprazole is not removed by hemodialysis.

In case of overdosage, treatment should be symptomatic and supportive. Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H + , K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

12.2Pharmacodynamics Antisecretory Activity Under maximal acid stimulatory conditions using pentagastrin, a dose-dependent decrease in gastric acid output occurs after a single dose of oral (20 to 80 mg) or a single dose of intravenous (20 to 120 mg) pantoprazole in healthy subjects. Pantoprazole given once daily results in increasing inhibition of gastric acid secretion. Following the initial oral dose of 40 mg pantoprazole, a 51% mean inhibition was achieved by 2.5 hours.

With once-a-day dosing for 7 days, the mean inhibition was increased to 85%. Pantoprazole suppressed acid secretion in excess of 95% in half of the subjects. Acid secretion had returned to normal within a week after the last dose of pantoprazole; there was no evidence of rebound hypersecretion.In a series of dose-response studies, pantoprazole, at oral doses ranging from 20 to 120 mg, caused dose-related increases in median basal gastric pH and in the percent of time gastric pH was > 3 and > 4.

Treatment with 40 mg of pantoprazole produced significantly greater increases in gastric pH than the 20 mg dose. Doses higher than 40 mg (60, 80, 120 mg) did not result in further significant increases in median gastric pH. The effects of pantoprazole on median pH from one double-blind crossover study are shown in Table 4.

Table 4: Effect of Single Daily Doses of Oral Pantoprazole on Intragastric pH ——————— Median pH on day 7 ——————— Time Placebo 20 mg 40 mg 80 mg 8 a.m. - 8 a.m. (24 hours) 1.3 2.9* 3.8*# 3.9*# 8 a.m. - 10 p.m. (Daytime) 1.6 3.2* 4.4*# 4.8*# 10 p.m. - 8 a.m.

(Nighttime) 1.2 2.1* 3* 2.6* * Significantly different from placebo # Significantly different from 20 mg Serum Gastrin Effects Fasting serum gastrin levels were assessed in two double-blind studies of the acute healing of erosive esophagitis (EE) in which 682 patients with gastroesophageal reflux disease (GERD) received 10, 20, or 40 mg of pantoprazole sodium for up to 8 weeks. At 4 weeks of treatment there was an increase in mean gastrin levels of 7%, 35%, and 72% over pretreatment values in the 10, 20, and 40 mg treatment groups, respectively.

A similar increase in serum gastrin levels was noted at the 8-week visit with mean increases of 3%, 26%, and 84% for the three pantoprazole dose groups. Median serum gastrin levels remained within normal limits during maintenance therapy with Pantoprazole Sodium Delayed-Release Tablets. In long-term international studies involving over 800 patients, a 2- to 3-fold mean increase from the pretreatment fasting serum gastrin level was observed in the initial months of treatment with pantoprazole at doses of 40 mg per day during GERD maintenance studies and 40 mg or higher per day in patients with refractory GERD.

Fasting serum gastrin levels generally remained at approximately 2 to 3 times baseline for up to 4 years of periodic follow-up in clinical trials. Following short-term treatment with pantoprazole sodium, elevated gastrin levels return to normal by at least 3 months. Enterochromaffin-Like (ECL) Cell Effects In 39 patients treated with oral pantoprazole 40 mg to 240 mg daily (majority receiving 40 mg to 80 mg) for up to 5 years, there was a moderate increase in ECL-cell density, starting after the first year of use, which appeared to plateau after 4 years.

In a nonclinical study in Sprague-Dawley rats, lifetime exposure (24 months) to pantoprazole at doses of 0.5 to 200 mg/kg/day resulted in dose-related increases in gastric ECL cell prol… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 88 words ▾

12.1Mechanism of Action Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H + , K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

📦 How Supplied / Storage and Handling 66 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted H126 on one side with black ink and plain on the other side. They are supplied as follows: NDC 68071-4864-9 BOTTLES OF 90 Storage Store pantoprazole sodium delayed-release tablets, USP at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4-dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S .

1.5H2O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane.

The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.

Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate.

The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2. structure.jpg

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Adverse Reactions • Hypersensitivity Reactions [see Contraindications (4)] • 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 B-12) Deficiency [see Warnings and Precautions (5.6)] • Hypomagnesemia [see Warnings and Precautions ( 5.7)] Drug Interactions Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [Contraindications (4)], high dose methotrexate [Warnings and Precautions (5.10)] and over-the-counter medications.

Pregnancy Inform female patients of reproductive potential that pantoprazole sodium may cause fetal harm and to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)]. Administration • Caution patients that pantoprazole sodium delayed-release tablets should not be split, crushed, or chewed. • Tell patients that pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. • Let patients know that concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.

Manufactured for: Camber Pharmaceuticals Inc. Piscataway, NJ 08854 By: HETERO TM Hetero Labs Limited Unit V, Polepally, Jadcherla, Mahaboob Nagar – 509 301, India. Barcode Revised: August 2017 address2.jpg

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Pantoprazole Sodium Delayed-Release Tablets pan toe’ pra zole soe’ dee um Read this Medication Guide before you start taking pantoprazole sodium delayed-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about pantoprazole sodium delayed-release tablets? Pantoprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Pantoprazole sodium delayed-release tablets can cause serious side effects, including: • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including pantoprazole sodium delayed-release tablets, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with pantoprazole sodium delayed-release tablets. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea.

Pantoprazole sodium delayed-release tablets may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. • Bone fractures People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk offractures of the hip, wrist or spine.

You should take pantoprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take pantoprazole sodium delayed-release tablet. • 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 pantoprazole sodium delayed-release tablet, 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. Pantoprazole sodium delayed-release tablets can have other serious side effects.

See “What are the possible side effects of pantoprazole sodium delayed-release tablets?” What are pantoprazole sodium delayed-release tablets? Pantoprazole sodium delayed-release tablets are a prescription medicine called a proton pump inhibitor (PPI). Pantoprazole sodium delayed-release tablet reduces the amount of acid in your stomach.

Pantoprazole sodium delayed-release tablets are used in adults: •for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) and to relieve symptoms caused by gastroesophageal reflux disease (GERD). If needed, your doctor may decide to prescribe another 8 weeks of pantoprazole sodium delayed-release tablet. • to maintain the healing of acid-related damage to the lining of the esophagus and help prevent return of heartburn symptoms caused by GERD. It is not known if pantoprazole sodium delayed-release tablet is safe and effective if used longer than 12 months (1 year).

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. •for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

Pantoprazole sodium delayed-release tablets are used in children 5 years of age and older for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) caused by GERD. It is not known if pant… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 106 words ▾

8.3Nursing Mothers Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium. The clinical relevance of this finding is not known.

Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pantoprazole Sodium Delayed-Release Tablets are prepared as enteric-coated tablets so that absorption of pantoprazole begins only after the tablet leaves the stomach. Peak serum concentration (C max ) and area under the serum concentration time curve (AUC) increase in a manner proportional to oral and intravenous doses from 10 mg to 80 mg. Pantoprazole does not accumulate, and its pharmacokinetics are unaltered with multiple daily dosing.

Following oral or intravenous administration, the serum concentration of pantoprazole declines biexponentially, with a terminal elimination half-life of approximately one hour. In extensive metabolizers with normal liver function receiving an oral dose of the enteric-coated 40 mg pantoprazole tablet, the peak concentration (C max ) is 2.5 mcg/mL; the time to reach the peak concentration (t max ) is 2.5 h, and the mean total area under the plasma concentration versus time curve (AUC) is 4.8 mcg•h/mL (range 1.4 to 13.3 mcg•h/mL).

Following intravenous administration of pantoprazole to extensive metabolizers, its total clearance is 7.6 to14 L/h, and its apparent volume of distribution is 11 to

23.6L. Absorption After administration of a single or multiple oral 40 mg doses of Pantoprazole Sodium Delayed-Release Tablets, the peak plasma concentration of pantoprazole was achieved in approximately 2.5 hours, and C max was 2.5 mcg/mL. Pantoprazole undergoes little first-pass metabolism, resulting in an absolute bioavailability of approximately 77%.

Pantoprazole absorption is not affected by concomitant administration of antacids. Administration of Pantoprazole Sodium Delayed-Release Tablets with food may delay its absorption up to 2 hours or longer; however, the C max and the extent of pantoprazole absorption (AUC) are not altered. Thus, Pantoprazole Sodium Delayed-Release Tablets may be taken without regard to timing of meals.

Distribution The apparent volume of distribution of pantoprazole is approximately 11 to

23.6L, distributing mainly in extracellular fluid. The serum protein binding of pantoprazole is about 98%, primarily to albumin. Elimination Metabolism Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system.

Pantoprazole metabolism is independent of the route of administration (intravenous or oral). The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4. There is no evidence that any of the pantoprazole metabolites have significant pharmacologic activity.

Excretion After a single oral or intravenous dose of 14 C-labeled pantoprazole to healthy, normal metabolizer subjects, approximately 71% of the dose was excreted in the urine, with 18% excreted in the feces through biliary excretion. There was no renal excretion of unchanged pantoprazole. Specific Population Age: Geriatric Population Only slight to moderate increases in the pantoprazole AUC (43%) and C max (26%) were found in elderly volunteers (64 to 76 years of age) after repeated oral administration, compared with younger subjects. [see Use in Specific Populations ( 8.5 )].

Age: Pediatric Population The pharmacokinetics of pantoprazole were studied in children less than 16 years of age in four randomized, open-label clinical trials in pediatric patients with presumed/proven GERD. A pediatric granule formulation was studied in children through 5 years of age, and Pantoprazole Sodium Delayed-Release Tablets were studied in children older than 5 years. In a population PK analysis, total clearance increased with increasing bodyweight in a non-linear fashion.

The total clearance also increased with increasing age only in children under 3 years of age. Neonate through 5 years of age See Use in Specific Populations ( 8.4 ) . Children and Adolescents 6 through 16 Years of Age The pharmacokinetics of Pantoprazole Sodium Delayed-Release Tablets were evaluated in children ages 6 through 16 years with a c… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics Antisecretory Activity Under maximal acid stimulatory conditions using pentagastrin, a dose-dependent decrease in gastric acid output occurs after a single dose of oral (20 to 80 mg) or a single dose of intravenous (20 to 120 mg) pantoprazole in healthy subjects. Pantoprazole given once daily results in increasing inhibition of gastric acid secretion. Following the initial oral dose of 40 mg pantoprazole, a 51% mean inhibition was achieved by 2.5 hours.

With once-a-day dosing for 7 days, the mean inhibition was increased to 85%. Pantoprazole suppressed acid secretion in excess of 95% in half of the subjects. Acid secretion had returned to normal within a week after the last dose of pantoprazole; there was no evidence of rebound hypersecretion.In a series of dose-response studies, pantoprazole, at oral doses ranging from 20 to 120 mg, caused dose-related increases in median basal gastric pH and in the percent of time gastric pH was > 3 and > 4.

Treatment with 40 mg of pantoprazole produced significantly greater increases in gastric pH than the 20 mg dose. Doses higher than 40 mg (60, 80, 120 mg) did not result in further significant increases in median gastric pH. The effects of pantoprazole on median pH from one double-blind crossover study are shown in Table 4.

Table 4: Effect of Single Daily Doses of Oral Pantoprazole on Intragastric pH ——————— Median pH on day 7 ——————— Time Placebo 20 mg 40 mg 80 mg 8 a.m. - 8 a.m. (24 hours) 1.3 2.9* 3.8*# 3.9*# 8 a.m. - 10 p.m. (Daytime) 1.6 3.2* 4.4*# 4.8*# 10 p.m. - 8 a.m.

(Nighttime) 1.2 2.1* 3* 2.6* * Significantly different from placebo # Significantly different from 20 mg Serum Gastrin Effects Fasting serum gastrin levels were assessed in two double-blind studies of the acute healing of erosive esophagitis (EE) in which 682 patients with gastroesophageal reflux disease (GERD) received 10, 20, or 40 mg of pantoprazole sodium for up to 8 weeks. At 4 weeks of treatment there was an increase in mean gastrin levels of 7%, 35%, and 72% over pretreatment values in the 10, 20, and 40 mg treatment groups, respectively.

A similar increase in serum gastrin levels was noted at the 8-week visit with mean increases of 3%, 26%, and 84% for the three pantoprazole dose groups. Median serum gastrin levels remained within normal limits during maintenance therapy with Pantoprazole Sodium Delayed-Release Tablets. In long-term international studies involving over 800 patients, a 2- to 3-fold mean increase from the pretreatment fasting serum gastrin level was observed in the initial months of treatment with pantoprazole at doses of 40 mg per day during GERD maintenance studies and 40 mg or higher per day in patients with refractory GERD.

Fasting serum gastrin levels generally remained at approximately 2 to 3 times baseline for up to 4 years of periodic follow-up in clinical trials. Following short-term treatment with pantoprazole sodium, elevated gastrin levels return to normal by at least 3 months. Enterochromaffin-Like (ECL) Cell Effects In 39 patients treated with oral pantoprazole 40 mg to 240 mg daily (majority receiving 40 mg to 80 mg) for up to 5 years, there was a moderate increase in ECL-cell density, starting after the first year of use, which appeared to plateau after 4 years.

In a nonclinical study in Sprague-Dawley rats, lifetime exposure (24 months) to pantoprazole at doses of 0.5 to 200 mg/kg/day resulted in dose-related increases in gastric ECL cell proliferation and gastric neuroendocrine (NE)-cell tumors. Gastric NE-cell tumors in rats may result from chronic elevation of serum gastrin concentrations. The high density of ECL cells in the rat stomach makes this species highly susceptible to the proliferative effects of elevated gastrin concentrations produced by PPIs.

However, there were no observed elevations in serum gastrin following the administration of pantoprazole at a dose of 0.5 mg/kg/day. In a separate study, a gastric NE-cell tumor without concomitant ECL… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Pantoprazole Sodium Delayed-Release Tablets were used in the following clinical trials.

14.1Erosive Esophagitis (EE) Associated with Gastroesophageal Reflux Disease (GERD) Adult Patients A US multicenter, double-blind, placebo-controlled study of pantoprazole sodium 10 mg, 20 mg, or 40 mg once daily was conducted in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above (Hetzel-Dent scale). In this study, approximately 25% of enrolled patients had severe EE of grade 3, and 10% had grade 4. The percentages of patients healed (per protocol, n = 541) in this study are shown in Table 8.

Table 8: Erosive Esophagitis Healing Rates (Per Protocol) ––––––––––––––– Pantoprazole sodium ––––––––––––––– Placebo Week 10 mg daily (n = 153) 20 mg daily (n = 158) 40 mg daily (n = 162) (n = 68) 4 45.6% + 58.4% + # 75% + * 14.3% 8 66% + 83.5% + # 92.6% + * 39.7% + (p < 0.001) pantoprazole sodium versus placebo * (p < 0.05) versus 10 mg or 20 mg pantoprazole sodium # (p < 0.05) versus 10 mg pantoprazole sodium In this study, all pantoprazole sodium treatment groups had significantly greater healing rates than the placebo group.

This was true regardless of H. pylori status for the 40 mg and 20 mg pantoprazole sodium treatment groups. The 40 mg dose of pantoprazole sodium resulted in healing rates significantly greater than those found with either the 20 mg or 10 mg dose. A significantly greater proportion of patients taking pantoprazole sodium 40 mg experienced complete relief of daytime and nighttime heartburn and the absence of regurgitation, starting from the first day of treatment, compared with placebo.

Patients taking pantoprazole sodium consumed significantly fewer antacid tablets per day than those taking placebo. Pantoprazole sodium 40 mg and 20 mg once daily were also compared with nizatidine 150 mg twice daily in a US multicenter, double-blind study of 243 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above. The percentages of patients healed (per protocol, n = 212) are shown in Table 9.

Table 9: Erosive Esophagitis Healing Rates (Per Protocol) ––––––––––––––– Pantoprazole sodium ––––––––––––––– Nizatidine Week 20 mg daily (n = 72) 40 mg daily (n = 70) 150 mg twice daily (n = 70) 4 61.4% + 64% + 22.2% 8 79.2% + 82.9% + � 41.4% + (p < 0.001) pantoprazole sodium versus nizatidine Once-daily treatment with pantoprazole sodium 40 mg or 20 mg resulted in significantly superior rates of healing at both 4 and 8 weeks compared with twice-daily treatment with 150 mg of nizatidine. For the 40 mg treatment group, significantly greater healing rates compared to nizatidine were achieved regardless of the H. pylori status.

A significantly greater proportion of the patients in the pantoprazole sodium treatment groups experienced complete relief of nighttime heartburn and regurgitation, starting on the first day and of daytime heartburn on the second day, compared with those taking nizatidine 150 mg twice daily. Patients taking pantoprazole sodium consumed significantly fewer antacid tablets per day than those taking nizatidine. Pediatric Patients Ages 5 Years through 16 Years The efficacy of pantoprazole sodium in the treatment of EE associated with GERD in pediatric patients ages 5 years through 16 years is extrapolated from adequate and well-conducted trials in adults, as the pathophysiology is thought to be the same.

Four pediatric patients with endoscopically diagnosed EE were studied in multicenter, randomized, double-blind, parallel-treatment trials. Children with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of pantoprazole sodium delayed-release tablets (20 mg or 40 mg). All 4 patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks.

14.2Long-Term Maintenance of Healing of Erosive Esophagitis Two independent, multicenter, randomized, double-blind, comparat… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis,Mutagenesis,Impairment of Fertility In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with pantoprazole doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50 kg person dosed at 40 mg/day. In the gastric fundus, treatment at 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas.

Rare gastrointestinal tumors associated with pantoprazole treatment included an adenocarcinoma of the duodenum at 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus at 200 mg/kg/day. In the liver, treatment at 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. In the thyroid gland, treatment at 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.

In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with doses of 5 to 50 mg/kg/day of pantoprazole, approximately 1 to 10 times the recommended human dose based on body surface area. In the gastric fundus, treatment at 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of pantoprazole.

In a 24-month carcinogenicity study, B6C3F1 mice were treated orally with doses of 5 to 150 mg/kg/day of pantoprazole , 0.5 to 15 times the recommended human dose based on body surface area. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment at 5 to 150 mg/kg/day also produced gastric-fundic ECL cell hyperplasia.

A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive. Pantoprazole was positive in the in vitro human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. Equivocal results were observed in the in vivo rat liver DNA covalent binding assay.

Pantoprazole was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis (UDS) assay with rat hepatocytes, the in vitro AS52/GPT mammalian cell-forward gene mutation assay, the in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cells, and the in vivo rat bone marrow cell chromosomal aberration assay. There were no effects on fertility or reproductive performance when pantoprazole was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area).

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

13.1Carcinogenesis,Mutagenesis,Impairment of Fertility In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with pantoprazole doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50 kg person dosed at 40 mg/day. In the gastric fundus, treatment at 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas.

Rare gastrointestinal tumors associated with pantoprazole treatment included an adenocarcinoma of the duodenum at 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus at 200 mg/kg/day. In the liver, treatment at 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. In the thyroid gland, treatment at 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.

In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with doses of 5 to 50 mg/kg/day of pantoprazole, approximately 1 to 10 times the recommended human dose based on body surface area. In the gastric fundus, treatment at 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of pantoprazole.

In a 24-month carcinogenicity study, B6C3F1 mice were treated orally with doses of 5 to 150 mg/kg/day of pantoprazole , 0.5 to 15 times the recommended human dose based on body surface area. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment at 5 to 150 mg/kg/day also produced gastric-fundic ECL cell hyperplasia.

A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive. Pantoprazole was positive in the in vitro human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. Equivocal results were observed in the in vivo rat liver DNA covalent binding assay.

Pantoprazole was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis (UDS) assay with rat hepatocytes, the in vitro AS52/GPT mammalian cell-forward gene mutation assay, the in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cells, and the in vivo rat bone marrow cell chromosomal aberration assay. There were no effects on fertility or reproductive performance when pantoprazole was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area).

📄 Recent Major Changes 18 words ▾

Warnings and Precautions, Atrophic Gastritis removed (5.2) 10/2016 Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (5.5) 10/2016

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PDP

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

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

Medicare Part D (outpatient prescription) spending for Pantoprazole Sodium — the program that covers self-administered drugs. 30 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 Pantoprazole Sodium. 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
$79.44M
Claims incl. refills
6.9M
Beneficiaries
4.9M
Spend / beneficiary
$16.30
Spend / claim
$11.55
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PANTOPRAZOLE SODIUM (this brand).

Top reported reactions

Fatigue20,774
Nausea17,856
Diarrhoea17,557
Dyspnoea17,287
Pain15,532
Headache13,322
Vomiting12,781

Age at onset

Neonate271
Infant49
Child214
Adolescent251
Adult23,758
Elderly25,724

Reporter sex

251,646 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization116,362
Death28,519
Life-threatening18,480
Disabling10,304
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 25,002 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NuCare 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.
← 68071-4860-04 · NuCare 68071-4865-04 · NuCare →
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.