ibuprofen

Generic: ibuprofen

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 400 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5819
Product ID 50090-5819_928aea26-2b55-4e1c-9a7d-9aeddfdb32a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078329
Listing Expiration 2026-12-31
Marketing Start 2018-08-24

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 500905819
Hyphenated Format 50090-5819

Supplemental Identifiers

RxCUI
197805
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 ANDA078329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 16 TABLET, FILM COATED in 1 BOTTLE (50090-5819-0)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-5819-1)
  • 100 TABLET, FILM COATED in 1 BOTTLE (50090-5819-3)
  • 20 TABLET, FILM COATED in 1 BOTTLE (50090-5819-4)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-5819-8)
source: ndc

Packages (5)

50090-5819-0 16 TABLET, FILM COATED in 1 BOTTLE (50090-5819-0) 50090-5819-1 30 TABLET, FILM COATED in 1 BOTTLE (50090-5819-1) 50090-5819-3 100 TABLET, FILM COATED in 1 BOTTLE (50090-5819-3) 50090-5819-4 20 TABLET, FILM COATED in 1 BOTTLE (50090-5819-4) 50090-5819-8 60 TABLET, FILM COATED in 1 BOTTLE (50090-5819-8)

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": "928aea26-2b55-4e1c-9a7d-9aeddfdb32a5", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197805"], "spl_set_id": ["400faee1-f662-470e-bcd6-7711dfaf9ba2"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "16 TABLET, FILM COATED in 1 BOTTLE (50090-5819-0)", "package_ndc": "50090-5819-0", "marketing_start_date": "20211019"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5819-1)", "package_ndc": "50090-5819-1", "marketing_start_date": "20211019"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50090-5819-3)", "package_ndc": "50090-5819-3", "marketing_start_date": "20211019"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (50090-5819-4)", "package_ndc": "50090-5819-4", "marketing_start_date": "20211019"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-5819-8)", "package_ndc": "50090-5819-8", "marketing_start_date": "20211019"}], "brand_name": "Ibuprofen", "product_id": "50090-5819_928aea26-2b55-4e1c-9a7d-9aeddfdb32a5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50090-5819", "generic_name": "Ibuprofen", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA078329", "marketing_category": "ANDA", "marketing_start_date": "20180824", "listing_expiration_date": "20261231"}