ibuprofen

Generic: ibuprofen

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 400 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-5853
Product ID 0904-5853_9316ff41-1d6d-4538-821c-6835bfce15eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075682
Listing Expiration 2026-12-31
Marketing Start 2009-06-10

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 09045853
Hyphenated Format 0904-5853

Supplemental Identifiers

RxCUI
197805 197806 197807
UNII
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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA075682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (0904-5853-40)
  • 100 TABLET in 1 BOTTLE (0904-5853-60)
  • 100 BLISTER PACK in 1 CARTON (0904-5853-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

0904-5853-40 500 TABLET in 1 BOTTLE (0904-5853-40) 0904-5853-60 100 TABLET in 1 BOTTLE (0904-5853-60) 0904-5853-61 100 BLISTER PACK in 1 CARTON (0904-5853-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

ibuprofen (400 mg/1)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9316ff41-1d6d-4538-821c-6835bfce15eb", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["ba86e936-ef72-43e5-aebf-f2c788fe2266"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (0904-5853-40)", "package_ndc": "0904-5853-40", "marketing_start_date": "20090610"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (0904-5853-60)", "package_ndc": "0904-5853-60", "marketing_start_date": "20090610"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-5853-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-5853-61", "marketing_start_date": "20090610"}], "brand_name": "Ibuprofen", "product_id": "0904-5853_9316ff41-1d6d-4538-821c-6835bfce15eb", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0904-5853", "generic_name": "Ibuprofen", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA075682", "marketing_category": "ANDA", "marketing_start_date": "20090610", "listing_expiration_date": "20261231"}