acetaminophen and ibuprofen

Generic: acetaminophen and ibuprofen

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and ibuprofen
Generic Name acetaminophen and ibuprofen
Labeler walgreen company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
WALGREEN COMPANY

Identifiers & Regulatory

Product NDC 0363-4081
Product ID 0363-4081_4618fbfc-8baf-e491-e063-6394a90ad817
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216999
Listing Expiration 2026-12-31
Marketing Start 2024-12-04

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 03634081
Hyphenated Format 0363-4081

Supplemental Identifiers

RxCUI
2387532
UPC
0311917070896
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 acetaminophen and ibuprofen (source: ndc)
Generic Name acetaminophen and ibuprofen (source: ndc)
Application Number ANDA216999 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0363-4081-78) / 80 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

0363-4081-78 1 BOTTLE in 1 CARTON (0363-4081-78) / 80 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (250 mg/1) ibuprofen (125 mg/1)

Linked Drug Pages (1)

Acetaminophen and Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4618fbfc-8baf-e491-e063-6394a90ad817", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0311917070896"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["2789fdef-2d8e-6247-e063-6394a90a974b"], "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": ["WALGREEN COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-4081-78)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0363-4081-78", "marketing_start_date": "20241204"}], "brand_name": "Acetaminophen and Ibuprofen", "product_id": "0363-4081_4618fbfc-8baf-e491-e063-6394a90ad817", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0363-4081", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "WALGREEN COMPANY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and Ibuprofen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA216999", "marketing_category": "ANDA", "marketing_start_date": "20241204", "listing_expiration_date": "20261231"}