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United States · US · US:42571-433_3b0aa4df-ee1f-e4e3-e063-6394a90a4c66
FAMOTIDINE
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11425714334550 mL in 1 BOTTLE (42571-433-45)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A217842
AB
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": "42571-433_3b0aa4df-ee1f-e4e3-e063-6394a90a4c66",
"productndc": "42571-433",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "217842",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG/5ML",
"product_no": "001",
"approval_date": "Sep 14, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "FAMOTIDINE",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA217842",
"marketing_category": "ANDA",
"nonproprietary_name": "FAMOTIDINE",
"start_marketing_date": "20231201",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BA03.
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