NDC Code(s) : 23155-191-10, 23155-191-01, 23155-192-10, 23155-192-01
Packager : Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

bupropion Hydrochloridebupropion Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-191
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
STARCH, CORN(UNII: O8232NY3SJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
HYPROMELLOSES(UNII: 3NXW29V3WO)
STEARIC ACID(UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code 191
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23155-191-101000 in 1 BOTTLE Type 0: Not a Combination Product19/08/2016
2NDC:23155-191-01100 in 1 BOTTLE Type 0: Not a Combination Product19/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206975 08/19/2016
bupropion Hydrochloridebupropion Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-192
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
STARCH, CORN(UNII: O8232NY3SJ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
HYPROMELLOSES(UNII: 3NXW29V3WO)
STEARIC ACID(UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color RED Score no score
Shape ROUND Size 12 mm
Flavor Imprint Code 192
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23155-192-101000 in 1 BOTTLE Type 0: Not a Combination Product19/08/2016
2NDC:23155-192-01100 in 1 BOTTLE Type 0: Not a Combination Product19/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206975 08/19/2016

LABELER - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)

REGISTRANT - Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.(189630168)

Establishment
Name Address ID/FEI Business Operations
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. 189630168 ANALYSIS(23155-191, 23155-192), LABEL(23155-191, 23155-192), MANUFACTURE(23155-191, 23155-192), PACK(23155-191, 23155-192)

PRINCIPAL DISPLAY PANEL

NDC 23155-191-01

Three Times Daily (After Initial Titration)

buPROPion Hydrochloride Tablets, USP

75 mg

WARNING: Do not use with other medicines that contain bupropion hydrochloride.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

100 Tablets

Rx only

75 mg label

PRINCIPAL DISPLAY PANEL

NDC 23155-192-01

Three Times Daily (After Initial Titration)

buPROPion Hydrochloride Tablets, USP

100 mg

WARNING: Do not use with other medicines that contain bupropion hydrochloride.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

100 Tablets

Rx only

label 100 mg