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Prescription medicine · generic available

Famotidine

Brand names: Pepcid

Also sold without a prescription: Famotidine (over the counter) →

Drug class: Histamine-2 Receptor Antagonist

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

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

NoBoxed warning
None listedFDA shortage list
8Recalls (FDA reports)
68Companies
2001First FDA approval on file

Quick answers

What is Famotidine used for?
The FDA-approved label (Famotidine, Sagent Pharmaceuticals, June 6, 2026) says: “Famotidine Injection is indicated for use in hospitalized adults, or as an alternative to oral famotidine in adults, for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by endoscopy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Famotidine have a boxed warning?
No. None of the 154 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Famotidine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Famotidine been recalled?
FDA enforcement reports list 8 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 Famotidine?
68 companies list prescription products of Famotidine in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Proficient Rx LP.

What Famotidine is used for

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

Famotidine Injection is indicated for use in hospitalized adults, or as an alternative to oral famotidine in adults, for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by endoscopy. …

— FDA label: Famotidine, Sagent Pharmaceuticals, effective June 6, 2026. Read the full label on DailyMed →

The FDA has 154 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.

0 of 154 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Powder, for suspension · Injection, solution · Tablet, coated · Injection · For suspension · Powder, for solution
RouteOral · Intravenous
Prescription products192 in the FDA NDC Directory
Brand namesPepcid

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 Famotidine, by strength and form
Strength and formGeneric or brandPharmacies pay
famotidine 10 mg/mL
injection		 Generic $0.3027 per mL
famotidine 10 mg/mL
injection, solution		 Generic $0.3027 per mL
famotidine 20 mg
tablet		 Generic $0.0282 per tablet
famotidine 20 mg
tablet, coated		 Generic $0.0282 per tablet
famotidine 20 mg
tablet, film coated		 Generic $0.0282 per tablet
famotidine 40 mg
tablet		 Generic $0.0478 per tablet
famotidine 40 mg
tablet, coated		 Generic $0.0478 per tablet
famotidine 40 mg
tablet, film coated		 Generic $0.0478 per tablet
famotidine 40 mg/5 mL
for suspension		 Generic $0.1273 per mL
famotidine 40 mg/5 mL
powder, for suspension		 Generic $0.0674–$0.4942 per mL
16 packages, lowest to highest

NADAC list of November 4, 2026; these prices took effect on 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
NDA219935
FAMOTIDINE		 SagentJuly 16, 2025 —

Generic approvals (39)

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-0809-2026

    CGMP Deviations

    Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338- — Baxter Healthcare Corporation

  2. November 6, 2025 · Class I · Ongoing · D-0182-2026

    Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

    Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale). — Fresenius Kabi USA, LLC

  3. January 20, 2021 · Class II · Terminated · D-0290-2021

    Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.

    Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99 — Aurobindo Pharma USA Inc.

  4. June 17, 2020 · Class III · Terminated · D-1392-2020

    TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.

    Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12 — HF Acquisition Co. LLC

  5. July 24, 2017 · Class II · Terminated · D-1056-2017

    Failed Tablet/Capsule Specification; out of specification for tablet weight

    Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60 — Teva Pharmaceuticals USA

  6. May 2, 2017 · Class III · Terminated · D-1127-2017

    CGMP Deviations

    Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01 — Lupin Pharmaceuticals Inc.

  7. June 20, 2014 · Class III · Terminated · D-1484-2014

    Failed Impurity/Degradation Specification; 12-month stability time point

    Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset — Novel Laboratories, Inc.

  8. April 24, 2014 · Class II · Terminated · D-0293-2015

    Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

    Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41. — Baxter Healthcare Corp.

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)104094, 104095, 199739, 204441, 284245, 310273, 310274, 1743833, 2727402, 2727403
SPL set ID of the quoted label9710995d-b518-40ce-bc2b-8b5dcf002c31
FDA labels (SPL)154
FDA applicationsNDA219935, 39 ANDA
Active ingredients (FDA)FAMOTIDINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Famotidine, Sagent Pharmaceuticals, effective June 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 →

Report an error → · Information for medicine makers