NDC Code(s) : 64679-101-01, 64679-101-02, 64679-101-03, 64679-101-07, 64679-101-08, 64679-101-05, 64679-105-01, 64679-105-02, 64679-105-03, 64679-105-04, 64679-105-07, 64679-105-05, 64679-107-01, 64679-107-02, 64679-107-03, 64679-107-04, 64679-107-07, 64679-107-05
Packager : Wockhardt USA LLC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIUM CHLORIDE(UNII: 01Q9PC255D)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE Score no score
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code W;101
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-101-0130 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
2NDC:64679-101-0260 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
3NDC:64679-101-03100 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
4NDC:64679-101-07500 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
5NDC:64679-101-0510 in 1 CARTON 15/05/2012
5NDC:64679-101-0810 in 1 BLISTER PACK Type 0: Not a Combination Product15/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201331 05/15/2012
Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIUM CHLORIDE(UNII: 01Q9PC255D)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PURPLE Score no score
Shape ROUND (biconvex) Size 10 mm
Flavor Imprint Code W;105
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-105-0130 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
2NDC:64679-105-0260 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
3NDC:64679-105-03100 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
4NDC:64679-105-04500 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
5NDC:64679-105-0510 in 1 CARTON 15/05/2012
5NDC:64679-105-0710 in 1 BLISTER PACK Type 0: Not a Combination Product15/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201331 05/15/2012
Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIUM CHLORIDE(UNII: 01Q9PC255D)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 12 mm
Flavor Imprint Code W;107
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-107-0130 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
2NDC:64679-107-0260 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
3NDC:64679-107-03100 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
4NDC:64679-107-04500 in 1 BOTTLE Type 0: Not a Combination Product15/05/2012
5NDC:64679-107-0510 in 1 CARTON 15/05/2012
5NDC:64679-107-0710 in 1 BLISTER PACK Type 0: Not a Combination Product15/05/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201331 05/15/2012

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Wockhardt USA LLC.(170508365)

Establishment
Name Address ID/FEI Business Operations
Wockhardt Limited 676257570 ANALYSIS(64679-101, 64679-105, 64679-107), MANUFACTURE(64679-101, 64679-105, 64679-107), LABEL(64679-101, 64679-105, 64679-107), PACK(64679-101, 64679-105, 64679-107)

PRINCIPAL DISPLAY PANEL

DRUG: Bupropion Hydrochloride

GENERIC: Bupropion Hydrochloride

DOSAGE: Film-coated extended-release tablets (Twice daily)

ADMINSTRATION: Oral

NDC: 64679-101-01

STRENGTH: 100 mg

COLOR: Blue

SHAPE: Round (biconvex)

SCORE: no score

SIZE: 8 mm

IMPRINT: W;101

QTY: 30 Tablets

100 mg Label

DRUG: Bupropion Hydrochloride

GENERIC: Bupropion Hydrochloride

DOSAGE: Film-coated extended-release tablets (Twice daily)

ADMINSTRATION: Oral

NDC: 64679-105-02

STRENGTH: 150 mg

COLOR: Purple

SHAPE: Round (biconvex)

SCORE: no score

SIZE: 10 mm

IMPRINT: W;105

QTY: 60 Tablets

100 mg Label

DRUG: Bupropion Hydrochloride

GENERIC: Bupropion Hydrochloride

DOSAGE: Film-coated extended-release tablets (Twice daily)

ADMINSTRATION: Oral

NDC: 64679-107-03

STRENGTH: 200 mg

COLOR: Pink

SHAPE: Round (biconvex)

SCORE: no score

SIZE: 12 mm

IMPRINT: W;107

QTY: 100 Tablets

100 mg Label