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United States · US · US:83324-008_14a35301-b682-06ca-e063-6394a90a7bc6
famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCHAIN DRUG MARKETING ASSOCIATION, INC.
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183324008501 CONTAINER in 1 CARTON (83324-008-50) / 50 TABLET, FILM COATED in 1 CONTAINER
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A215766
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": "83324-008_14a35301-b682-06ca-e063-6394a90a7bc6",
"productndc": "83324-008",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215766",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 8, 2021"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "002",
"approval_date": "Nov 8, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "famotidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215766",
"marketing_category": "ANDA",
"nonproprietary_name": "famotidine",
"start_marketing_date": "20240306",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BA03.
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