MedPath

Ibuprofen

Ibuprofen Tablets, USP

Approved
Approval ID

f6b28247-4798-4412-a103-2185a028dd05

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 28, 2010

Manufacturers
FDA

Altura Pharmaceuticals, Inc.

DUNS: 006890545

Products 3

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

Ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63874-324
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification

INGREDIENTS (1)

IBUPROFENActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB

Ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63874-322
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification

INGREDIENTS (1)

IBUPROFENActive
Quantity: 400 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB

Ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63874-323
Application NumberANDA078558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification

INGREDIENTS (1)

IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB

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Ibuprofen - FDA Drug Approval Details