ibuprofen

Generic: ibuprofen

Labeler: fsa store inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler fsa store inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
FSA STORE INC.

Identifiers & Regulatory

Product NDC 81522-119
Product ID 81522-119_37cb3dd7-010e-fc60-e063-6394a90ae846
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079174
Listing Expiration 2026-12-31
Marketing Start 2023-01-11

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 81522119
Hyphenated Format 81522-119

Supplemental Identifiers

RxCUI
310965
UPC
0099581912062
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 ANDA079174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (81522-119-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 500 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-119-05)
source: ndc

Packages (2)

81522-119-03 1 BOTTLE, PLASTIC in 1 CARTON (81522-119-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 81522-119-05 500 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-119-05)

Ingredients (1)

ibuprofen (200 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": "37cb3dd7-010e-fc60-e063-6394a90ae846", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0099581912062"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["ec6b015d-e72e-89c4-e053-2a95a90af81c"], "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": ["FSA STORE INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (81522-119-03)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "81522-119-03", "marketing_start_date": "20230503"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-119-05)", "package_ndc": "81522-119-05", "marketing_start_date": "20230111"}], "brand_name": "Ibuprofen", "product_id": "81522-119_37cb3dd7-010e-fc60-e063-6394a90ae846", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "81522-119", "generic_name": "Ibuprofen", "labeler_name": "FSA STORE INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079174", "marketing_category": "ANDA", "marketing_start_date": "20230111", "listing_expiration_date": "20261231"}