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United States · US · US:55154-4313_c2ae9c82-2f61-45df-977e-4f2e0f0d58e2

Famotidine

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515443130
    10 BLISTER PACK in 1 BAG (55154-4313-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A075718
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": "55154-4313_c2ae9c82-2f61-45df-977e-4f2e0f0d58e2",
  "productndc": "55154-4313",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075718",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Apr 16, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Famotidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075718",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20010416",
  "active_numerator_strength": "20"
}

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