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United States · US · US:71205-535_37ca9d4f-3fed-421a-a18f-a9954c00a90c

Famotidine

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7120553506
    6 TABLET, FILM COATED in 1 BOTTLE (71205-535-06)
  • ndc11
    7120553510
    10 TABLET, FILM COATED in 1 BOTTLE (71205-535-10)
  • ndc11
    7120553530
    30 TABLET, FILM COATED in 1 BOTTLE (71205-535-30)
  • ndc11
    7120553560
    60 TABLET, FILM COATED in 1 BOTTLE (71205-535-60)
  • ndc11
    7120553578
    180 TABLET, FILM COATED in 1 BOTTLE (71205-535-78)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A206530
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": "71205-535_37ca9d4f-3fed-421a-a18f-a9954c00a90c",
  "productndc": "71205-535",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206530",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Dec 22, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Famotidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206530",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20151222",
  "active_numerator_strength": "20"
}

Related drugs

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