Basic Information
Fenoprofen Calcium
53217-169
Regulatory Information
53217-169
NDA017604
C73605
February 22, 2017
USA
These highlights do not include all the information needed to use Fenoprofen Calcium Capsules, USP safely and effectively. See full prescribing information for Fenoprofen Calcium Capsules, USP. Fenoprofen Calcium Capsules, USP for oral use Initial U.S. Approval: 1982
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
801503249
Active Ingredients
CROSPOVIDONE
Code: 2S7830E561
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
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
FENOPROFEN
Code: RA33EAC7KY