🇺🇸
United States · US · US:25021-755_82835fd5-d117-4b63-82c2-fe5642fc04dd
Famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11250217550525 VIAL in 1 CARTON (25021-755-05) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
N219935
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": "INTRAVENOUS",
"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": "25021-755_82835fd5-d117-4b63-82c2-fe5642fc04dd",
"productndc": "25021-755",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "219935",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG/5ML (4MG/ML)",
"product_no": "001",
"approval_date": "Jul 16, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG/10ML (4MG/ML)",
"product_no": "002",
"approval_date": "Jul 16, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG/50ML (4MG/ML)",
"product_no": "003",
"approval_date": "Jul 16, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "Famotidine",
"active_ingred_unit": "mg/mL",
"application_number": "NDA219935",
"marketing_category": "NDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20251015",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code A02BA03.
Access this data programmatically
Query Famotidine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.