NDC Code(s) : 0093-5512-89, 0093-5513-89, 0093-5514-89
Packager : Teva Pharmaceuticals USA Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CarbamazepineCarbamazepine CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5512
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE(UNII: 33CM23913M)
(CARBAMAZEPINE - UNII:33CM23913M) 		CARBAMAZEPINE100 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POLYETHYLENE GLYCOL 4500(UNII: TVH7653921)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBITAN MONOLAURATE(UNII: 6W9PS8B71J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color GREEN (light-green) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code 93;5512;93;5512
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-5512-89120 in 1 BOTTLE Type 0: Not a Combination Product15/07/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078592 07/15/2013
CarbamazepineCarbamazepine CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5513
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE(UNII: 33CM23913M)
(CARBAMAZEPINE - UNII:33CM23913M) 		CARBAMAZEPINE200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POLYETHYLENE GLYCOL 4500(UNII: TVH7653921)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBITAN MONOLAURATE(UNII: 6W9PS8B71J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color GRAY (light-gray), GREEN (light-green) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 93;5513;93;5513
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-5513-89120 in 1 BOTTLE Type 0: Not a Combination Product02/11/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078592 02/11/2013
CarbamazepineCarbamazepine CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5514
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE(UNII: 33CM23913M)
(CARBAMAZEPINE - UNII:33CM23913M) 		CARBAMAZEPINE300 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 1450(UNII: OJ4Z5Z32L4)
POLYETHYLENE GLYCOL 4500(UNII: TVH7653921)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBITAN MONOLAURATE(UNII: 6W9PS8B71J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POVIDONES(UNII: FZ989GH94E)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color BLACK, GREEN (light-green) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code 93;5514;93;5514
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-5514-89120 in 1 BOTTLE Type 0: Not a Combination Product02/11/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078592 02/11/2013

PRINCIPAL DISPLAY PANEL

Carbamazepine Extended-Release Capsules 100 mg 120s Label

PRINCIPAL DISPLAY PANEL

Carbamazepine Extended-Release Capsules 200 mg 120s Label

PRINCIPAL DISPLAY PANEL

Carbamazepine Extended-Release Capsules 300 mg 120s Label