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 800 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7283
Product ID 50090-7283_2f42bfa3-a3a5-40fd-bbca-973a984d4d2c
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 500907283
Hyphenated Format 50090-7283

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 ANDA202413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (50090-7283-0)
  • 15 TABLET, FILM COATED in 1 BOTTLE (50090-7283-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-7283-2)
  • 45 TABLET, FILM COATED in 1 BOTTLE (50090-7283-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-7283-4)
  • 100 TABLET, FILM COATED in 1 BOTTLE (50090-7283-5)
  • 21 TABLET, FILM COATED in 1 BOTTLE (50090-7283-7)
  • 12 TABLET, FILM COATED in 1 BOTTLE (50090-7283-8)
  • 40 TABLET, FILM COATED in 1 BOTTLE (50090-7283-9)
source: ndc

Packages (9)

Ingredients (1)

ibuprofen (800 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2f42bfa3-a3a5-40fd-bbca-973a984d4d2c", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197807"], "spl_set_id": ["b0917020-f0ec-4d07-8fbf-c1eb909f466b"], "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, FILM COATED in 1 BOTTLE (50090-7283-0)", "package_ndc": "50090-7283-0", "marketing_start_date": "20241008"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (50090-7283-1)", "package_ndc": "50090-7283-1", "marketing_start_date": "20241008"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-7283-2)", "package_ndc": "50090-7283-2", "marketing_start_date": "20241008"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (50090-7283-3)", "package_ndc": "50090-7283-3", "marketing_start_date": "20241008"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-7283-4)", "package_ndc": "50090-7283-4", "marketing_start_date": "20241008"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50090-7283-5)", "package_ndc": "50090-7283-5", "marketing_start_date": "20241008"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (50090-7283-7)", "package_ndc": "50090-7283-7", "marketing_start_date": "20241008"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (50090-7283-8)", "package_ndc": "50090-7283-8", "marketing_start_date": "20241008"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE (50090-7283-9)", "package_ndc": "50090-7283-9", "marketing_start_date": "20241008"}], "brand_name": "Ibuprofen", "product_id": "50090-7283_2f42bfa3-a3a5-40fd-bbca-973a984d4d2c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50090-7283", "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": "ANDA202413", "marketing_category": "ANDA", "marketing_start_date": "20240523", "listing_expiration_date": "20261231"}