ibuprofen

Generic: ibuprofen

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 600 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-395
Product ID 69367-395_786c8d96-734d-4905-ae64-490c41bfbf40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202413
Listing Expiration 2026-12-31
Marketing Start 2024-05-23

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 69367395
Hyphenated Format 69367-395

Supplemental Identifiers

RxCUI
197805 197806 197807
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 ANDA202413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69367-395-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69367-395-05)
source: ndc

Packages (2)

69367-395-01 100 TABLET, FILM COATED in 1 BOTTLE (69367-395-01) 69367-395-05 500 TABLET, FILM COATED in 1 BOTTLE (69367-395-05)

Ingredients (1)

ibuprofen (600 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": "786c8d96-734d-4905-ae64-490c41bfbf40", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d"], "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": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69367-395-01)", "package_ndc": "69367-395-01", "marketing_start_date": "20240523"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69367-395-05)", "package_ndc": "69367-395-05", "marketing_start_date": "20240523"}], "brand_name": "Ibuprofen", "product_id": "69367-395_786c8d96-734d-4905-ae64-490c41bfbf40", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69367-395", "generic_name": "Ibuprofen", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "600 mg/1"}], "application_number": "ANDA202413", "marketing_category": "ANDA", "marketing_start_date": "20240523", "listing_expiration_date": "20261231"}