🇺🇸
United States · US · US:0143-9150_8438b258-011d-4734-86f7-be0334c9db34
COMBOGESIC IV
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014391501010 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
N215320
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": "INTRAVENOUS",
"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": "0143-9150_8438b258-011d-4734-86f7-be0334c9db34",
"productndc": "0143-9150",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215320",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)",
"product_no": "001",
"approval_date": "Oct 17, 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 IV",
"active_ingred_unit": "mg/100mL; mg/100mL",
"application_number": "NDA215320",
"marketing_category": "NDA",
"nonproprietary_name": "acetaminophen and ibuprofen injection",
"start_marketing_date": "20240205",
"active_numerator_strength": "1000; 300"
}Related drugs
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