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Prescription medicine · generic available

Pantoprazole sodium

Brand names: Protonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

Some labelsBoxed warning
None listedFDA shortage list
11Recalls (FDA reports)
67Companies
2000First FDA approval on file

Quick answers

What is Pantoprazole sodium used for?
The FDA-approved label (Protonix I.V., Cardinal Health 107, LLC, April 6, 2026) says: “PROTONIX I.V. is indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older. • pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of PROTONIX I.V. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Pantoprazole sodium have a boxed warning?
The label we quote has no boxed warning, but 4 of 132 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Pantoprazole sodium?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Pantoprazole sodium been recalled?
FDA enforcement reports list 11 recalls of products of this medicine; the newest started August 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Pantoprazole sodium?
67 companies list prescription products of Pantoprazole sodium in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Cardinal Health 107, LLC and Bryant Ranch Prepack.

What Pantoprazole sodium is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

PROTONIX I.V. is indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older. • pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of PROTONIX I.V. …

— FDA label: Protonix I.V., Cardinal Health 107, LLC, effective April 6, 2026. Read the full label on DailyMed →

The FDA has 132 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Gastroesophageal reflux disease (GERD)

Related medical specialties

Gastroenterology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

4 of 132 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, delayed release · Injection, powder, for solution · Injection, powder, lyophilized, for solution · Granule, delayed release · Injection, solution · Powder, for solution · For suspension · Tablet · Suspension
RouteOral · Intravenous
Prescription products166 in the FDA NDC Directory
Brand namesProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V.

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Pantoprazole sodium, by strength and form
Strength and formGeneric or brandPharmacies pay
pantoprazole sodium 20 mg
tablet, delayed release		 Generic $0.0421 per tablet
pantoprazole sodium 20 mg
tablet, delayed release		 Brand: Protonix Delayed-Release $14.31 per tablet
pantoprazole sodium 40 mg
for suspension		 Generic $3.11 per unit
pantoprazole sodium 40 mg
granule, delayed release		 Generic $3.11 per unit
pantoprazole sodium 40 mg
granule, delayed release		 Brand: Protonix Delayed-Release $14.08 per unit
pantoprazole sodium 40 mg
injection, powder, for solution		 Generic $2.37 per unit
pantoprazole sodium 40 mg
injection, powder, lyophilized, for solution		 Generic $2.37 per unit
pantoprazole sodium 40 mg
suspension		 Generic $3.11 per unit
pantoprazole sodium 40 mg
tablet		 Generic $0.0367 per tablet
pantoprazole sodium 40 mg
tablet, delayed release		 Generic $0.0367 per tablet
pantoprazole sodium 40 mg
tablet, delayed release		 Brand: Protonix Delayed-Release $14.24 per tablet
pantoprazole sodium 40 mg/10 mL
injection, powder, for solution		 Generic $2.37 per unit
pantoprazole sodium 40 mg/10 mL
injection, powder, lyophilized, for solution		 Generic $2.37 per unit

NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA020987
PROTONIX		 Wyeth PharmsFebruary 2, 2000 43, latest July 18, 2023
2023: Labeling · 2022: Labeling · 2020: Labeling
NDA020988
PROTONIX IV		 Wyeth PharmsMarch 22, 2001 50, latest August 12, 2024
2024: Efficacy · 2023: Labeling · 2022: Labeling
NDA022020
PROTONIX		 Wyeth PharmsNovember 14, 2007 17, latest July 18, 2023
2023: Labeling · 2022: Labeling · 2020: Labeling
NDA209463
PANTOPRAZOLE SODIUM		 HikmaJune 30, 2017 5, latest July 18, 2023
2023: Labeling · 2022: Labeling · 2020: Labeling
NDA217512
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE		 Baxter Hlthcare CorpFebruary 14, 2024 —

Generic approvals (28)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. August 6, 2026 · Class II · Ongoing · D-0812-2026

    CGMP Deviations

    Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-96 — Baxter Healthcare Corporation

  2. March 26, 2026 · Class II · Ongoing · D-0484-2026

    Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

    Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, M — Hetero Labs Limited (Unit V)

  3. September 5, 2023 · Class II · Terminated · D-1148-2023

    Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

    Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distr — BE PHARMACEUTICALS AG

  4. March 14, 2023 · Class II · Ongoing · D-0530-2023

    CGMP Deviations: Discoloration

    Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar — Hetero USA Inc

  5. July 25, 2022 · Class II · Terminated · D-0068-2023

    Discoloration

    Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Onl — SUN PHARMACEUTICAL INDUSTRIES INC

  6. April 11, 2022 · Class II · Terminated · D-0852-2022

    CGMP deviations: tablets cracking

    Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, N — Torrent Pharma Inc

  7. March 15, 2021 · Class II · Terminated · D-0506-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA — Cardinal Health Inc.

  8. February 5, 2021 · Class III · Terminated · D-0251-2021

    Failed Impurity/Degradation Specifications

    Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-38 — SUN PHARMACEUTICAL INDUSTRIES INC

  9. December 4, 2017 · Class I · Terminated · D-0340-2018

    Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

    Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00 — AuroMedics Pharma LLC

  10. December 16, 2016 · Class III · Terminated · D-0470-2017

    Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

    Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00 — Aurobindo Pharma USA Inc

  11. November 22, 2016 · Class III · Terminated · D-0516-2017

    Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.

    PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, — Pfizer Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)251872, 283669, 284400, 314200, 352125, 763306, 763308, 885257, 2675781, 2675784 … (+1)
SPL set ID of the quoted label50802e19-72d3-4130-8d14-eb94361b38e7
FDA labels (SPL)132
FDA applicationsNDA020987, NDA020988, NDA022020, NDA209463, NDA217512, 28 ANDA
Active ingredients (FDA)PANTOPRAZOLE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Protonix I.V., Cardinal Health 107, LLC, effective April 6, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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