Bupropion Hydrochloride XL (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 300 mg

ONCE-DAILY

NDC 69367-289-09

Rx only

buPROPion HCl
Extended-Release

Tablets, USP (XL)

300 mg

WARNING: Do not use in combination with Zyban®

or any other medicines that contain bupropion hydrochloride.
90 Tablets

bupropion-300-90ct
(click image for full-size original)
BUPROPION HYDROCHLORIDE XL
bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-288
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE
ETHYLCELLULOSES
GLYCERYL DIBEHENATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SILICON DIOXIDE
Product Characteristics
Color white (white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 150;XL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-288-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69367-288-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207224 10/01/2017
BUPROPION HYDROCHLORIDE XL
bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-289
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE
GLYCERYL DIBEHENATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SILICON DIOXIDE
ETHYLCELLULOSES
Product Characteristics
Color white (white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 300;XL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-289-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:69367-289-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207224 10/01/2017
Labeler — Westminster Pharmaceuticals, LLC (079516651)
Registrant — Anbison Laboratory Co., Ltd. (420804645)
Establishment
Name Address ID/FEI Operations
CSPC Ouyi Pharmaceutical Co., Ltd. 421303775 manufacture (69367-288), manufacture (69367-289)

Revised: 10/2021 Westminster Pharmaceuticals, LLC

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