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United States · US · US:25000-124_1c69fac1-3052-45b1-ab46-a3b523347de1

Famotidine 20 mg

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2500012468
    300 TABLET, COATED in 1 BOTTLE (25000-124-68)
  • ndc11
    2500012484
    1 BOTTLE in 1 CARTON (25000-124-84) / 25 TABLET, COATED in 1 BOTTLE
  • ndc11
    2500012494
    5 BLISTER PACK in 1 CARTON (25000-124-94) / 5 TABLET, COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A217543
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": "25000-124_1c69fac1-3052-45b1-ab46-a3b523347de1",
  "productndc": "25000-124",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "217543",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 8, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Mar 8, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Famotidine 20 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217543",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine 20 mg",
  "start_marketing_date": "20250523",
  "active_numerator_strength": "20"
}

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