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United States · US · US:0338-5197_bb9e28a8-1076-4c48-9a19-cc43bcd64862
Famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11033851974112 BAG in 1 CARTON (0338-5197-41) / 50 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A075591
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": "0338-5197_bb9e28a8-1076-4c48-9a19-cc43bcd64862",
"productndc": "0338-5197",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "075591",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "0.4MG/ML",
"product_no": "001",
"approval_date": "May 10, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "Famotidine",
"active_ingred_unit": "mg/50mL",
"application_number": "ANDA075591",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20010510",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BA03.
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