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United States · US · US:68788-4088_fd5d15b9-b1b5-48ef-ba41-8a43a7642e94

Famotidine

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6878840883
    30 TABLET, COATED in 1 BOTTLE, PLASTIC (68788-4088-3)
  • ndc11
    6878840884
    14 TABLET, COATED in 1 BOTTLE, PLASTIC (68788-4088-4)
  • ndc11
    6878840886
    60 TABLET, COATED in 1 BOTTLE, PLASTIC (68788-4088-6)
  • ndc11
    6878840889
    90 TABLET, COATED in 1 BOTTLE, PLASTIC (68788-4088-9)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A217669
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": "68788-4088_fd5d15b9-b1b5-48ef-ba41-8a43a7642e94",
  "productndc": "68788-4088",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "217669",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Dec 20, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Dec 20, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Famotidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217669",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20260317",
  "active_numerator_strength": "20"
}

Related drugs

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