Famotidine

Orange BookUNIISPLATC A02BA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeA02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
8280498100
100 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-00)
ndc11
8280498120
20 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-20)
ndc11
8280498130
30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-30)
ndc11
8280498155
500 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-55)
ndc11
8280498160
60 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-60)
ndc11
8280498167
270 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-67)
ndc11
8280498172
120 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-72)
ndc11
8280498178
180 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-78)
ndc11
8280498190
90 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-90)

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": "82804-981_7335a9b3-33fb-4343-bc31-b26dd58c0a1c",
  "productndc": "82804-981",
  "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": "20240909",
  "active_numerator_strength": "40"
}

Related drugs

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