NDC Code 68180-320-09 - Bupropion Hydrochloride

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

Bupropion Hydrochloride Bupropion Hydrochloride TABLET, 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
AMMONIA(UNII: 5138Q19F1X)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GLYCERYL BEHENATE/EICOSADIOATE(UNII: 73CJJ317SR)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)

Product Characteristics
Color	WHITE (off-white to pale yellow)	Score	no score
Shape	ROUND	Size	7 mm
Flavor		Imprint Code	L015
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68180-319-06	30 in 1 BOTTLE Type 0: Not a Combination Product	14/06/2017
2	NDC:68180-319-09	90 in 1 BOTTLE Type 0: Not a Combination Product	14/06/2017
3	NDC:68180-319-02	500 in 1 BOTTLE Type 0: Not a Combination Product	14/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090693	06/14/2017

Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)	BUPROPION HYDROCHLORIDE	300 mg

Ingredient Name	Strength
Inactive Ingredients
AMMONIA(UNII: 5138Q19F1X)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GLYCERYL BEHENATE/EICOSADIOATE(UNII: 73CJJ317SR)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)

Product Characteristics
Color	WHITE (off-white to pale yellow)	Score	no score
Shape	ROUND	Size	9 mm
Flavor		Imprint Code	L016
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68180-320-06	30 in 1 BOTTLE Type 0: Not a Combination Product	14/06/2017
2	NDC:68180-320-09	90 in 1 BOTTLE Type 0: Not a Combination Product	14/06/2017
3	NDC:68180-320-02	500 in 1 BOTTLE Type 0: Not a Combination Product	14/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090693	06/14/2017

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

NDC 68180-320-09
API & Excipient Details