ibuprofen

Generic: ibuprofen

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

Drug Facts

Product Profile

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

ibuprofen 50 mg/1.25mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-5463
Product ID 0904-5463_baccf3cf-e20d-468c-9b23-d39361a9a302
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075217
Listing Expiration 2026-12-31
Marketing Start 2000-01-08

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 09045463
Hyphenated Format 0904-5463

Supplemental Identifiers

RxCUI
204442
UNII
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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA075217 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0904-5463-35) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

0904-5463-35 1 BOTTLE in 1 CARTON (0904-5463-35) / 15 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "baccf3cf-e20d-468c-9b23-d39361a9a302", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["b4962985-47e6-4389-874f-76742b086e2f"], "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"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-5463-35)  / 15 mL in 1 BOTTLE", "package_ndc": "0904-5463-35", "marketing_start_date": "20000108"}], "brand_name": "ibuprofen", "product_id": "0904-5463_baccf3cf-e20d-468c-9b23-d39361a9a302", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0904-5463", "generic_name": "ibuprofen", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA075217", "marketing_category": "ANDA", "marketing_start_date": "20000108", "listing_expiration_date": "20261231"}