NDC Code(s) : 24979-101-06, 24979-101-07, 24979-101-02, 24979-102-06, 24979-102-07, 24979-102-02
Packager : TWi 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: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:24979-101-0630 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/08/2018
2NDC:24979-101-0790 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/08/2018
3NDC:24979-101-02500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210081 08/30/2018
Bupropion Hydrochloride bupropion hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:24979-102-0630 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/08/2018
2NDC:24979-102-0790 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/08/2018
3NDC:24979-102-02500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210081 08/30/2018

LABELER - TWi Pharmaceuticals, Inc.(658402052)

REGISTRANT - TWi Pharmaceuticals, Inc.(658402052)

Establishment
Name Address ID/FEI Business Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 manufacture(24979-101, 24979-102), analysis(24979-101, 24979-102)

Establishment
Name Address ID/FEI Business Operations
Apace Packaging LLC 361961142 pack(24979-101, 24979-102)

Establishment
Name Address ID/FEI Business Operations
BORA PHARMACEUTICAL LABORATORIES INC. 656139511 pack(24979-101, 24979-102)

PRINCIPAL DISPLAY PANEL


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

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Bupropion Hydrochloride Extended-Release Tablets (XL), USP, 300 mg, 30-count

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