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United States · US · US:68071-4197_1a3b98e7-ec70-569d-e063-6394a90a4470
Famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11680714197330 TABLET in 1 BOTTLE (68071-4197-3)
- ndc11680714197660 TABLET in 1 BOTTLE (68071-4197-6)
- ndc11680714197990 TABLET in 1 BOTTLE (68071-4197-9)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A075805
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": "68071-4197_1a3b98e7-ec70-569d-e063-6394a90a4470",
"productndc": "68071-4197",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075805",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Apr 16, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "002",
"approval_date": "Apr 16, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "Famotidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075805",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20010416",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BA03.
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