Basic Information
Propafenone Hydrochloride
51407-477
Regulatory Information
51407-477
ANDA212928
C73584
January 8, 2024
USA
PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. 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 use Initial U.S. Approval: 1989
HUMAN PRESCRIPTION DRUG LABEL
3
Company Information
603184490
Active Ingredients
HYPROMELLOSE 2910 (3 MPA.S)
Code: 0VUT3PMY82
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
Active Moieties
PROPAFENONE
Code: 68IQX3T69U