FAMOTIDINE

Orange BookUNIISPLATC A02BA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeA02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7133597241
30 TABLET, FILM COATED in 1 BOTTLE (71335-9724-1)
ndc11
7133597242
60 TABLET, FILM COATED in 1 BOTTLE (71335-9724-2)
ndc11
7133597243
100 TABLET, FILM COATED in 1 BOTTLE (71335-9724-3)
ndc11
7133597244
90 TABLET, FILM COATED in 1 BOTTLE (71335-9724-4)
ndc11
7133597245
15 TABLET, FILM COATED in 1 BOTTLE (71335-9724-5)
ndc11
7133597246
120 TABLET, FILM COATED in 1 BOTTLE (71335-9724-6)
ndc11
7133597247
20 TABLET, FILM COATED in 1 BOTTLE (71335-9724-7)

Annotations

UNII (FDA Substance ID)

5QZO15J2Z8

FAMOTIDINE

RxCUI 4278

Orange Book

A215630

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5QZO15J2Z8",
    "rxcui": "4278",
    "inchikey": "XUFQPHANEAPEMJ-UHFFFAOYSA-N",
    "display_name": "FAMOTIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e53928f3-5181-490b-acfb-be8d4cea60a9": {
      "match": "brand_token",
      "title": "FAMOTIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71335-9724_e5c1db20-4893-4dc8-b577-a649ab230c8c",
  "productndc": "71335-9724",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215630",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Jan 7, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "FAMOTIDINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215630",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FAMOTIDINE",
  "start_marketing_date": "20220708",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code A02BA03.

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