NDC Code(s) : 68180-319-06, 68180-319-09, 68180-319-02, 68180-320-06, 68180-320-09, 68180-320-02
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-319
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
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-319-0630 in 1 BOTTLE Type 0: Not a Combination Product14/06/2017
2NDC:68180-319-0990 in 1 BOTTLE Type 0: Not a Combination Product14/06/2017
3NDC:68180-319-02500 in 1 BOTTLE Type 0: Not a Combination Product14/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090693 06/14/2017
Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-320-0630 in 1 BOTTLE Type 0: Not a Combination Product14/06/2017
2NDC:68180-320-0990 in 1 BOTTLE Type 0: Not a Combination Product14/06/2017
3NDC:68180-320-02500 in 1 BOTTLE Type 0: Not a Combination Product14/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090693 06/14/2017

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 677600414 MANUFACTURE(68180-319, 68180-320), PACK(68180-319, 68180-320)

PRINCIPAL DISPLAY PANEL

NDC 68180-319-06

Bupropion Hydrochloride Extended-release Tablets USP (XL)

150 mg

Rx only

Bottle of 30 Tablets

150 mg

NDC 68180-320-06

Bupropion Hydrochloride Extended-release Tablets USP (XL)

300 mg

Rx only

Bottle of 30 Tablets

150 mg