Propafenone
PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES
Approved
Approval ID
e4412a6a-ed4d-410d-8abb-86e1d7b72a3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
propafenone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-814
Application NumberANDA078540
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2011
FDA Product Classification
INGREDIENTS (18)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
PROPAFENONEActive
Quantity: 325 mg in 1 1
Code: 68IQX3T69U
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ETHANOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT