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United States · US · US:71610-399_ce00f657-538e-4b73-9126-1cff453be4aa
Famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11716103993030 TABLET in 1 BOTTLE (71610-399-30)
- ndc11716103996090 TABLET in 1 BOTTLE (71610-399-60)
- ndc117161039980180 TABLET in 1 BOTTLE (71610-399-80)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A078916
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": "71610-399_ce00f657-538e-4b73-9126-1cff453be4aa",
"productndc": "71610-399",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078916",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "May 22, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "002",
"approval_date": "May 22, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "Famotidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078916",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20160129",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BA03.
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