NDC Code(s) : 71335-1837-9, 71335-1837-1, 71335-1837-2, 71335-1837-3, 71335-1837-4, 71335-1837-5, 71335-1837-6, 71335-1837-7, 71335-1837-8
Packager : Bryant Ranch Prepack

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:71335-1837(NDC:70436-059)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
TALC(UNII: 7SEV7J4R1U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color purple Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code YH;177
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71335-1837-9100 in 1 BOTTLE Type 0: Not a Combination Product07/06/2022
2NDC:71335-1837-160 in 1 BOTTLE Type 0: Not a Combination Product05/05/2021
3NDC:71335-1837-290 in 1 BOTTLE Type 0: Not a Combination Product17/02/2022
4NDC:71335-1837-330 in 1 BOTTLE Type 0: Not a Combination Product26/04/2021
5NDC:71335-1837-4120 in 1 BOTTLE Type 0: Not a Combination Product07/06/2022
6NDC:71335-1837-545 in 1 BOTTLE Type 0: Not a Combination Product07/06/2022
7NDC:71335-1837-6180 in 1 BOTTLE Type 0: Not a Combination Product02/02/2022
8NDC:71335-1837-728 in 1 BOTTLE Type 0: Not a Combination Product07/06/2022
9NDC:71335-1837-856 in 1 BOTTLE Type 0: Not a Combination Product07/06/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211347 11/02/2020

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-1837), RELABEL(71335-1837)

PRINCIPAL DISPLAY PANEL

Bupropion HCL ER(12h) 150mg Tablet

Label