ibuprofen

Generic: ibuprofen

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 400 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-464
Product ID 53746-464_769cfd1d-35d7-4f1a-ad8b-1bf642e02075
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078558
Listing Expiration 2026-12-31
Marketing Start 2009-11-23

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 53746464
Hyphenated Format 53746-464

Supplemental Identifiers

RxCUI
197805 197806 197807
UPC
0353746465016 0353746464019 0353746466013
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 ANDA078558 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-464-01)
  • 500 TABLET in 1 BOTTLE (53746-464-05)
  • 30 TABLET in 1 BOTTLE (53746-464-30)
  • 60 TABLET in 1 BOTTLE (53746-464-60)
  • 90 TABLET in 1 BOTTLE (53746-464-90)
source: ndc

Packages (5)

53746-464-01 100 TABLET in 1 BOTTLE (53746-464-01) 53746-464-05 500 TABLET in 1 BOTTLE (53746-464-05) 53746-464-30 30 TABLET in 1 BOTTLE (53746-464-30) 53746-464-60 60 TABLET in 1 BOTTLE (53746-464-60) 53746-464-90 90 TABLET in 1 BOTTLE (53746-464-90)

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": "769cfd1d-35d7-4f1a-ad8b-1bf642e02075", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0353746465016", "0353746464019", "0353746466013"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["faebc392-0fd9-4c71-8471-beba10dda022"], "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": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-464-01)", "package_ndc": "53746-464-01", "marketing_start_date": "20091123"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-464-05)", "package_ndc": "53746-464-05", "marketing_start_date": "20091123"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (53746-464-30)", "package_ndc": "53746-464-30", "marketing_start_date": "20091123"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (53746-464-60)", "package_ndc": "53746-464-60", "marketing_start_date": "20091123"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (53746-464-90)", "package_ndc": "53746-464-90", "marketing_start_date": "20091123"}], "brand_name": "Ibuprofen", "product_id": "53746-464_769cfd1d-35d7-4f1a-ad8b-1bf642e02075", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53746-464", "generic_name": "Ibuprofen", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA078558", "marketing_category": "ANDA", "marketing_start_date": "20091123", "listing_expiration_date": "20261231"}