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United States · US · US:71335-2190_ca5b10e6-83a5-475c-8a04-9621381afcfc

Famotidine

Orange BookUNIISPLATC A02BA03

Last synced from FDA National Drug Code directory (United States) on

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
    7133521901
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2190-1)
  • ndc11
    7133521902
    60 TABLET, FILM COATED in 1 BOTTLE (71335-2190-2)
  • ndc11
    7133521903
    20 TABLET, FILM COATED in 1 BOTTLE (71335-2190-3)
  • ndc11
    7133521904
    90 TABLET, FILM COATED in 1 BOTTLE (71335-2190-4)
  • ndc11
    7133521905
    100 TABLET, FILM COATED in 1 BOTTLE (71335-2190-5)
  • ndc11
    7133521906
    10 TABLET, FILM COATED in 1 BOTTLE (71335-2190-6)
  • ndc11
    7133521907
    120 TABLET, FILM COATED in 1 BOTTLE (71335-2190-7)
  • ndc11
    7133521908
    50 TABLET, FILM COATED in 1 BOTTLE (71335-2190-8)
  • ndc11
    7133521909
    14 TABLET, FILM COATED in 1 BOTTLE (71335-2190-9)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A216441
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": "71335-2190_ca5b10e6-83a5-475c-8a04-9621381afcfc",
  "productndc": "71335-2190",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216441",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jun 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Jun 3, 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": "ANDA216441",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20220606",
  "active_numerator_strength": "20"
}

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