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Prescription medicine · generic available

Ranitidine

Also listed by the FDA as: ranitidine hydrochloride · ranitidine

Also sold without a prescription: Ranitidine (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
4Recalls (FDA reports)
6Companies
2000First FDA approval on file

Quick answers

What is Ranitidine used for?
The FDA-approved label (Ranitidine, Amneal Pharmaceuticals of New York LLC, May 1, 2026) says: “Ranitidine Tablets, USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ranitidine have a boxed warning?
No. None of the 5 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Ranitidine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ranitidine been recalled?
FDA enforcement reports list 4 recalls of products of this medicine; the newest started November 22, 2019 (Class II). A recall usually concerns specific lots, not every product.
Who makes Ranitidine?
6 companies list prescription products of Ranitidine in the FDA NDC Directory, including Amneal Pharmaceuticals of New York LLC, Atland Pharmaceuticals, LLC and Rising Pharma Holdings, Inc..

What Ranitidine is used for

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

Ranitidine Tablets, USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. …

— FDA label: Ranitidine, Amneal Pharmaceuticals of New York LLC, effective May 1, 2026. Read the full label on DailyMed →

The FDA has 5 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 5 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Capsule · Syrup
RouteOral
Prescription products12 in the FDA NDC Directory

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

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (5)

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. November 22, 2019 · Class II · Ongoing · D-0616-2020

    CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

    Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. — Amneal Pharmaceuticals, Inc.

  2. November 22, 2019 · Class II · Ongoing · D-0615-2020

    CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

    Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. — Amneal Pharmaceuticals, Inc.

  3. October 1, 2019 · Class II · Completed · D-0168-2020

    CGMP Deviations: Presence of NDMA impurity detected in product.

    Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05) — Dr. Reddy's Laboratories, Inc.

  4. October 1, 2019 · Class II · Completed · D-0180-2020

    CGMP Deviations: Presence of NDMA impurity detected in product.

    Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01) — Dr. Reddy's Laboratories, 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)198190, 198191, 198192, 198193, 705610
SPL set ID of the quoted labelb38a3332-5c54-453f-aeb7-070f830955c2
FDA labels (SPL)5
FDA applications5 ANDA
Active ingredients (FDA)RANITIDINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Ranitidine, Amneal Pharmaceuticals of New York LLC, effective May 1, 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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