NDC Code(s) : 51407-207-30, 51407-207-90, 51407-207-05, 51407-206-30, 51407-206-90, 51407-206-05
Packager : Golden State Medical Supply, 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:51407-207(NDC:24979-102)
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
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (White) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code T102
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51407-207-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/02/2019
2NDC:51407-207-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/02/2019
3NDC:51407-207-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210081 11/03/2017
Bupropion Hydrochloride bupropion hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-206(NDC:24979-101)
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
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (White) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code T101
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51407-206-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/02/2019
2NDC:51407-206-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/02/2019
3NDC:51407-206-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210081 11/03/2017

LABELER - Golden State Medical Supply, Inc.(603184490)

Establishment
Name Address ID/FEI Business Operations
Golden State Medical Supply, Inc. 603184490 relabel(51407-206, 51407-207), repack(51407-206, 51407-207)

PRINCIPAL DISPLAY PANEL


Bupropion Hydrochloride Extended-Release Tablets (XL), USP, 150 mg, 30-count

1407-206-30LB.jpg


Bupropion Hydrochloride Extended-Release Tablets (XL), USP, 300 mg, 500-count

1407-206-30LB.jpg