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
8280498000
100 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-00)
ndc11
8280498020
20 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-20)
ndc11
8280498030
30 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-30)
ndc11
8280498055
500 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-55)
ndc11
8280498060
60 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-60)
ndc11
8280498067
270 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-67)
ndc11
8280498072
120 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-72)
ndc11
8280498078
180 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-78)
ndc11
8280498090
90 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-90)

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": "82804-980_7335a9b3-33fb-4343-bc31-b26dd58c0a1c",
  "productndc": "82804-980",
  "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": "20"
}

Related drugs

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