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United States · US · US:80425-0329_2a9c0c91-2b34-4def-e063-6294a90a58ef

Famotidine

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8042503291
    30 TABLET, FILM COATED in 1 BOTTLE (80425-0329-1)
  • ndc11
    8042503292
    60 TABLET, FILM COATED in 1 BOTTLE (80425-0329-2)
  • ndc11
    8042503293
    90 TABLET, FILM COATED in 1 BOTTLE (80425-0329-3)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A215767
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": "80425-0329_2a9c0c91-2b34-4def-e063-6294a90a58ef",
  "productndc": "80425-0329",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215767",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Nov 4, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Famotidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215767",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20230424",
  "active_numerator_strength": "20"
}

Related drugs

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