FDA Product

Ibuprofen

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Ibuprofen

FDA Product Code

67296-1573

Regulatory Information

NDC Product Code

67296-1573

Application Number

ANDA202413

Marketing Category

C73584

Effective Date

January 20, 2020

Territorial Authority

USA

FDA Title

ibuprofen

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

5

Company Information

ManufacturerRedPharm Drug, Inc.

DUNS Number

828374897

Active Ingredients

Quantity: 800 mg in 1 1

Code: WK2XYI10QM

Class Code: ACTIB

Inactive Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CARNAUBA WAX

Code: R12CBM0EIZ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

PEG-20 SORBITAN STEARATE

Code: HD40WR33LC

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

CROSCARMELLOSE

Code: 029TFK992N

IBUPROFEN

Code: WK2XYI10QM

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