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United States · US · US:43386-500_82462011-668a-4fbd-9653-48049901eacc
Famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11433865001150 mL in 1 BOTTLE (43386-500-11)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A201695
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": "43386-500_82462011-668a-4fbd-9653-48049901eacc",
"productndc": "43386-500",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "201695",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG/5ML",
"product_no": "001",
"approval_date": "Dec 17, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "Famotidine",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA201695",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20121217",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BA03.
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