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FDA Approval

Ibuprofen

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
August 19, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen(800 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ibuprofen

Product Details

NDC Product Code
68071-2815
Application Number
ANDA078558
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 19, 2022
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
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