combogesic iv

Generic: acetaminophen and ibuprofen injection

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name combogesic iv
Generic Name acetaminophen and ibuprofen injection
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

acetaminophen 1000 mg/100mL, ibuprofen 300 mg/100mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9150
Product ID 0143-9150_8438b258-011d-4734-86f7-be0334c9db34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215320
Listing Expiration 2027-12-31
Marketing Start 2024-02-05

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439150
Hyphenated Format 0143-9150

Supplemental Identifiers

RxCUI
2673874 2673880
UNII
362O9ITL9D WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name combogesic iv (source: ndc)
Generic Name acetaminophen and ibuprofen injection (source: ndc)
Application Number NDA215320 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1000 mg/100mL
  • 300 mg/100mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01)
source: ndc

Packages (1)

0143-9150-10 10 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01)

Ingredients (2)

acetaminophen (1000 mg/100mL) ibuprofen (300 mg/100mL)

Linked Drug Pages (1)

COMBOGESIC IV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8438b258-011d-4734-86f7-be0334c9db34", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2673874", "2673880"], "spl_set_id": ["be408a5a-48e4-43c0-9cb1-bbf830b54f5b"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9150-10)  / 100 mL in 1 VIAL (0143-9150-01)", "package_ndc": "0143-9150-10", "marketing_start_date": "20240205"}], "brand_name": "COMBOGESIC IV", "product_id": "0143-9150_8438b258-011d-4734-86f7-be0334c9db34", "dosage_form": "INJECTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0143-9150", "generic_name": "acetaminophen and ibuprofen injection", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COMBOGESIC IV", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "1000 mg/100mL"}, {"name": "IBUPROFEN", "strength": "300 mg/100mL"}], "application_number": "NDA215320", "marketing_category": "NDA", "marketing_start_date": "20240205", "listing_expiration_date": "20271231"}