NDC Code 64679-105-05 - Bupropion Hydrochloride

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)	BUPROPION HYDROCHLORIDE	100 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-101-01	30 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
2	NDC:64679-101-02	60 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
3	NDC:64679-101-03	100 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
4	NDC:64679-101-07	500 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
5	NDC:64679-101-05	10 in 1 CARTON	15/05/2012
5	NDC:64679-101-08	10 in 1 BLISTER PACK Type 0: Not a Combination Product	15/05/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA201331	05/15/2012

Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)	BUPROPION HYDROCHLORIDE	150 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-105-01	30 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
2	NDC:64679-105-02	60 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
3	NDC:64679-105-03	100 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
4	NDC:64679-105-04	500 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
5	NDC:64679-105-05	10 in 1 CARTON	15/05/2012
5	NDC:64679-105-07	10 in 1 BLISTER PACK Type 0: Not a Combination Product	15/05/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA201331	05/15/2012

Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)	BUPROPION HYDROCHLORIDE	200 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-107-01	30 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
2	NDC:64679-107-02	60 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
3	NDC:64679-107-03	100 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
4	NDC:64679-107-04	500 in 1 BOTTLE Type 0: Not a Combination Product	15/05/2012
5	NDC:64679-107-05	10 in 1 CARTON	15/05/2012
5	NDC:64679-107-07	10 in 1 BLISTER PACK Type 0: Not a Combination Product	15/05/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

NDC 64679-105-05
API & Excipient Details