Basic Information
Topiramate
10370-368
Regulatory Information
10370-368
ANDA205976
C73584
March 9, 2023
USA
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for CAPSULES. for oral use Initial U.S. Approval: 1996
HUMAN PRESCRIPTION DRUG LABEL
10
Company Information
092733690
Active Ingredients
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
HYPROMELLOSE 2910 (5 MPA.S)
Code: R75537T0T4
Class Code: IACT
POVIDONE
Code: FZ989GH94E
Class Code: IACT
ETHYLCELLULOSE (10 MPA.S)
Code: 3DYK7UYZ62
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
Active Moieties
TOPIRAMATE
Code: 0H73WJJ391