FENOPROFEN CALCIUM

Basic Information

Product Name

FENOPROFEN CALCIUM

FDA Product Code

54288-131

Regulatory Information

NDC Product Code

54288-131

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

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

BROWN IRON OXIDE

Code: 1N032N7MFO

Class Code: IACT

FENOPROFEN CALCIUM

Quantity: 200 mg in 1 1

Code: 0X2CW1QABJ

Class Code: ACTIM

Active Moieties

FENOPROFEN

Code: RA33EAC7KY

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSPOVIDONE

SODIUM LAURYL SULFATE

MAGNESIUM STEARATE

TALC

GELATIN

TITANIUM DIOXIDE

BROWN IRON OXIDE

Active Moieties

FENOPROFEN