NDC Code(s) : 46708-118-31, 46708-118-91, 46708-127-31, 46708-127-71
Packager : Alembic Pharmaceuticals Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:46708-118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE75 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color ORANGE (LIGHT ORANGE) Score no score
Shape ROUND (ROUND) Size 11 mm
Flavor Imprint Code L295
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46708-118-31100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
2NDC:46708-118-911000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203013 06/18/2018
Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:46708-127
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape ROUND (ROUND) Size 12 mm
Flavor Imprint Code L296
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46708-127-31100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
2NDC:46708-127-71500 in 1 BOTTLE Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203013 06/18/2018

LABELER - Alembic Pharmaceuticals Limited(650574663)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE(46708-118, 46708-127)

PRINCIPAL DISPLAY PANEL

Bupropion Hydrochloride Tablets USP 75 mg (100 Tablets in one Bottle)

Each film-coated tablet contains 75 mg bupropion HCl USP.

46708-118-31
100

PRINCIPAL DISPLAY PANEL

Bupropion Hydrochloride Tablets, USP 100 mg (100 Tablets in one Bottle)
Each film-coated tablet contains: bupropion HCl USP ...........100 mg .
46708-127-31


100