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United States · US · US:25000-087_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402

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 · 5

  • ndc11
    2500008703
    1 BOTTLE in 1 CARTON (25000-087-03) / 30 TABLET, COATED in 1 BOTTLE
  • ndc11
    2500008705
    1 BOTTLE in 1 CARTON (25000-087-05) / 50 TABLET, COATED in 1 BOTTLE
  • ndc11
    2500008708
    1 BOTTLE in 1 CARTON (25000-087-08) / 100 TABLET, COATED in 1 BOTTLE
  • ndc11
    2500008736
    3 BLISTER PACK in 1 CARTON (25000-087-36) / 10 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    2500008782
    1 BOTTLE in 1 CARTON (25000-087-82) / 200 TABLET, COATED in 1 BOTTLE

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": "25000-087_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402",
  "productndc": "25000-087",
  "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": "20230310",
  "active_numerator_strength": "20"
}

Related drugs

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