🇺🇸
United States · US · US:72578-214_d0498b4c-d60a-4a93-b151-d3bc4658787a
Ibuprofen and Famotidine
Orange BookUNIISPLATC A02BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeA02BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11725782141690 TABLET in 1 BOTTLE (72578-214-16)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A218684
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": {
"aeee629b-255c-40d8-8e95-779aec00f723": {
"match": "brand_token",
"title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "72578-214_d0498b4c-d60a-4a93-b151-d3bc4658787a",
"productndc": "72578-214",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218684",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "26.6MG;800MG",
"product_no": "001",
"approval_date": "Feb 20, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE; IBUPROFEN",
"proprietary_name": "Ibuprofen and Famotidine",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA218684",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen and Famotidine",
"start_marketing_date": "20250601",
"active_numerator_strength": "26.6; 800"
}Related drugs
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