MedPath
FDA Product

Ibuprofen

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

Basic Information

Ibuprofen

50090-6886

Regulatory Information

50090-6886

ANDA213794

C73584

May 10, 2021

USA

Ibuprofen Tablets, USP Rx only

Human Prescription Drug Label

6

Company Information

830016429

Active Ingredients

IBUPROFEN

Quantity: 800 mg in 1 1

Code: WK2XYI10QM

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 101

Code: 7T9FYH5QMK

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

IBUPROFEN

Code: WK2XYI10QM

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