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United States · US · US:63323-739_7411dc23-e297-42cb-b491-b90d70c841a3
Famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633237391225 VIAL, SINGLE-DOSE in 1 TRAY (63323-739-12) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-739-11)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A075813
AP
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": "63323-739_7411dc23-e297-42cb-b491-b90d70c841a3",
"productndc": "63323-739",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "075813",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "001",
"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/mL",
"application_number": "ANDA075813",
"marketing_category": "ANDA",
"nonproprietary_name": "FAMOTIDINE",
"start_marketing_date": "20010315",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A02BA03.
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