Basic Information
propafenone hydrochloride
68462-409
Regulatory Information
68462-409
ANDA205268
C73584
May 31, 2020
USA
These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE extended-release capsules, for oral useInitial U.S. Approval: 1989
HUMAN PRESCRIPTION DRUG LABEL
7
Company Information
130597813
Active Ingredients
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
Active Moieties
PROPAFENONE
Code: 68IQX3T69U