FENOPROFEN CALCIUM

Basic Information

Product Name

FENOPROFEN CALCIUM

FDA Product Code

54288-132

Regulatory Information

NDC Product Code

54288-132

Application Number

NDA017604

Marketing Category

C73594

Effective Date

May 31, 2016

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use FENOPROFEN CALCIUM safely and effectively. See full prescribing information for Fenoprofen Calcium. FENOPROFEN CALCIUM, USP capsules, for oral use Initial U.S. Approval: 1982

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

FENOPROFEN CALCIUM

Quantity: 400 mg in 1 1

Code: 0X2CW1QABJ

Class Code: ACTIM

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

Active Moieties

FENOPROFEN

Code: RA33EAC7KY

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSPOVIDONE

MAGNESIUM STEARATE

TALC

TITANIUM DIOXIDE

SODIUM LAURYL SULFATE

D&C YELLOW NO. 10

FD&C BLUE NO. 1

FD&C YELLOW NO. 6

FD&C RED NO. 40

Active Moieties

FENOPROFEN