Bupropion Hydrochloride (XL) (Page 10 of 10)

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, 500-count

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BUPROPION HYDROCHLORIDE (XL) 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 (BUPROPION) BUPROPION HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (15 MPA.S)
GLYCERYL DIBEHENATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
SILICON DIOXIDE
ETHYLCELLULOSE (100 MPA.S)
POVIDONE, UNSPECIFIED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white (White) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code T101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-206-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:51407-206-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:51407-206-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210081 11/03/2017
BUPROPION HYDROCHLORIDE (XL) 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 (BUPROPION) BUPROPION HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (15 MPA.S)
GLYCERYL DIBEHENATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
SILICON DIOXIDE
ETHYLCELLULOSE (100 MPA.S)
POVIDONE, UNSPECIFIED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white (White) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code T102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-207-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:51407-207-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:51407-207-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
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 Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-206), repack (51407-206), relabel (51407-207), repack (51407-207)

Revised: 10/2021 Golden State Medical Supply, Inc.

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