🇺🇸
United States · US · US:72260-129_87eb0170-2030-48b2-8097-0073a7ad00d7
Combogesic
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAFT Pharmaceuticals US, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117226012901250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72260-129-01)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
N209471
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "362O9ITL9D",
"rxcui": "161",
"inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
"display_name": "ACETAMINOPHEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"be408a5a-48e4-43c0-9cb1-bbf830b54f5b": {
"match": "brand_token",
"title": "COMBOGESIC IV (ACETAMINOPHEN AND IBUPROFEN INJECTION) INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
"spl_version": "5",
"published_date": "2026-02-26"
}
},
"productid": "72260-129_87eb0170-2030-48b2-8097-0073a7ad00d7",
"productndc": "72260-129",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209471",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "325MG;97.5MG",
"product_no": "001",
"approval_date": "Mar 1, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; IBUPROFEN",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Combogesic",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA209471",
"marketing_category": "NDA",
"nonproprietary_name": "ACETAMINOPHEN and IBUPROFEN",
"start_marketing_date": "20250106",
"active_numerator_strength": "325; 97.5"
}Related drugs
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