combogesic

Generic: acetaminophen and ibuprofen

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

Drug Facts

Product Profile

Brand Name combogesic
Generic Name acetaminophen and ibuprofen
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, ibuprofen 97.5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-4009
Product ID 68788-4009_cd03b658-dba1-4a12-8f6f-ab00da499c05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209471
Listing Expiration 2026-12-31
Marketing Start 2025-09-04

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 687884009
Hyphenated Format 68788-4009

Supplemental Identifiers

RxCUI
2675760 2675765
UNII
362O9ITL9D WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 (source: ndc)
Generic Name acetaminophen and ibuprofen (source: ndc)
Application Number NDA209471 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 97.5 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4009-1)
source: ndc

Packages (1)

68788-4009-1 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4009-1)

Ingredients (2)

acetaminophen (325 mg/1) ibuprofen (97.5 mg/1)

Linked Drug Pages (1)

Combogesic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cd03b658-dba1-4a12-8f6f-ab00da499c05", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2675760", "2675765"], "spl_set_id": ["cd03b658-dba1-4a12-8f6f-ab00da499c05"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4009-1)", "package_ndc": "68788-4009-1", "marketing_start_date": "20250904"}], "brand_name": "Combogesic", "product_id": "68788-4009_cd03b658-dba1-4a12-8f6f-ab00da499c05", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68788-4009", "generic_name": "ACETAMINOPHEN and IBUPROFEN", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Combogesic", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "IBUPROFEN", "strength": "97.5 mg/1"}], "application_number": "NDA209471", "marketing_category": "NDA", "marketing_start_date": "20250904", "listing_expiration_date": "20261231"}