Bupropion Hydrochloride (Page 9 of 9)

Package/Label Display Panel

BuPROPion Hydrochloride Tab USP 100mg
(click image for full-size original)
BUPROPION HYDROCHLORIDE bupropion hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7988(NDC:60505-0157)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
D&C RED NO. 7
FUMARIC ACID
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
METHYLCELLULOSE (100 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code APO;BUP;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7988-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7988-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68788-7988-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076143 08/06/2021
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7988)

Revised: 04/2022 Preferred Pharmaceuticals Inc.

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