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
Routes
ORAL
Active Ingredients

ibuprofen 800 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5446
Product ID 50090-5446_3d7a2f69-acb6-4040-9cd4-519fa5a20067
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213794
Listing Expiration 2026-12-31
Marketing Start 2020-05-08

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 500905446
Hyphenated Format 50090-5446

Supplemental Identifiers

RxCUI
197807
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 ANDA213794 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (50090-5446-0)
  • 30 TABLET in 1 BOTTLE (50090-5446-2)
  • 45 TABLET in 1 BOTTLE (50090-5446-3)
  • 60 TABLET in 1 BOTTLE (50090-5446-4)
  • 100 TABLET in 1 BOTTLE (50090-5446-5)
  • 21 TABLET in 1 BOTTLE (50090-5446-7)
  • 12 TABLET in 1 BOTTLE (50090-5446-8)
  • 40 TABLET in 1 BOTTLE (50090-5446-9)
source: ndc

Packages (8)

50090-5446-0 10 TABLET in 1 BOTTLE (50090-5446-0) 50090-5446-2 30 TABLET in 1 BOTTLE (50090-5446-2) 50090-5446-3 45 TABLET in 1 BOTTLE (50090-5446-3) 50090-5446-4 60 TABLET in 1 BOTTLE (50090-5446-4) 50090-5446-5 100 TABLET in 1 BOTTLE (50090-5446-5) 50090-5446-7 21 TABLET in 1 BOTTLE (50090-5446-7) 50090-5446-8 12 TABLET in 1 BOTTLE (50090-5446-8) 50090-5446-9 40 TABLET in 1 BOTTLE (50090-5446-9)

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": "3d7a2f69-acb6-4040-9cd4-519fa5a20067", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197807"], "spl_set_id": ["f24582be-8d70-4848-bd54-e55fa28f394f"], "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": "10 TABLET in 1 BOTTLE (50090-5446-0)", "package_ndc": "50090-5446-0", "marketing_start_date": "20210122"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-5446-2)", "package_ndc": "50090-5446-2", "marketing_start_date": "20210122"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (50090-5446-3)", "package_ndc": "50090-5446-3", "marketing_start_date": "20240517"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-5446-4)", "package_ndc": "50090-5446-4", "marketing_start_date": "20210122"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (50090-5446-5)", "package_ndc": "50090-5446-5", "marketing_start_date": "20210122"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (50090-5446-7)", "package_ndc": "50090-5446-7", "marketing_start_date": "20210122"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (50090-5446-8)", "package_ndc": "50090-5446-8", "marketing_start_date": "20210122"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (50090-5446-9)", "package_ndc": "50090-5446-9", "marketing_start_date": "20210122"}], "brand_name": "Ibuprofen", "product_id": "50090-5446_3d7a2f69-acb6-4040-9cd4-519fa5a20067", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50090-5446", "generic_name": "Ibuprofen", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA213794", "marketing_category": "ANDA", "marketing_start_date": "20200508", "listing_expiration_date": "20261231"}