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United States · US · US:82804-228_702dd4fa-4a78-454d-91c5-493894750f7b
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 · 1
- ndc11828042283030 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-228-30)
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": "82804-228_702dd4fa-4a78-454d-91c5-493894750f7b",
"productndc": "82804-228",
"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
Other records sharing ATC code A02BA03.
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