ibuprofen

Generic: ibuprofen

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ibuprofen 800 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1103
Product ID 69238-1103_9fdca868-ff3e-4871-9921-9ef7adc577e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078329
Listing Expiration 2026-12-31
Marketing Start 2014-04-01

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 692381103
Hyphenated Format 69238-1103

Supplemental Identifiers

RxCUI
197805 197806 197807
UPC
0369238110159 0369238110357 0369238110258
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 ANDA078329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (69238-1103-5)
source: ndc

Packages (1)

69238-1103-5 500 TABLET, FILM COATED in 1 BOTTLE (69238-1103-5)

Ingredients (1)

ibuprofen (800 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": "9fdca868-ff3e-4871-9921-9ef7adc577e5", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0369238110159", "0369238110357", "0369238110258"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["e07d989d-1b0e-4cc1-abf2-93c8b208a29a"], "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 NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69238-1103-5)", "package_ndc": "69238-1103-5", "marketing_start_date": "20140401"}], "brand_name": "Ibuprofen", "product_id": "69238-1103_9fdca868-ff3e-4871-9921-9ef7adc577e5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69238-1103", "generic_name": "Ibuprofen", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA078329", "marketing_category": "ANDA", "marketing_start_date": "20140401", "listing_expiration_date": "20261231"}