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 · 9

ndc11
7133597481
30 TABLET, FILM COATED in 1 BOTTLE (71335-9748-1)
ndc11
7133597482
60 TABLET, FILM COATED in 1 BOTTLE (71335-9748-2)
ndc11
7133597483
20 TABLET, FILM COATED in 1 BOTTLE (71335-9748-3)
ndc11
7133597484
90 TABLET, FILM COATED in 1 BOTTLE (71335-9748-4)
ndc11
7133597485
100 TABLET, FILM COATED in 1 BOTTLE (71335-9748-5)
ndc11
7133597486
10 TABLET, FILM COATED in 1 BOTTLE (71335-9748-6)
ndc11
7133597487
120 TABLET, FILM COATED in 1 BOTTLE (71335-9748-7)
ndc11
7133597488
50 TABLET, FILM COATED in 1 BOTTLE (71335-9748-8)
ndc11
7133597489
14 TABLET, FILM COATED in 1 BOTTLE (71335-9748-9)

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": "71335-9748_c1158423-fee4-475a-a9ec-fd6dc16c5a8f",
  "productndc": "71335-9748",
  "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": "20"
}

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