🇺🇸
United States · US · US:43602-544_97d403fb-8a67-483d-8f9c-45dd16a31689
IBUPROFEN AND FAMOTIDINE
Orange BookUNIISPLATC A02BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscent Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA02BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114360254405500 TABLET in 1 BOTTLE (43602-544-05)
- ndc11436025443030 TABLET in 1 BOTTLE (43602-544-30)
- ndc11436025449090 TABLET in 1 BOTTLE (43602-544-90)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A216814
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": "43602-544_97d403fb-8a67-483d-8f9c-45dd16a31689",
"productndc": "43602-544",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216814",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "26.6MG;800MG",
"product_no": "001",
"approval_date": "Mar 15, 2023"
}
],
"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": "ANDA216814",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen and famotidine",
"start_marketing_date": "20221006",
"active_numerator_strength": "26.6; 800"
}Related drugs
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