Bupropion Hydrochloride SR (Page 9 of 9)

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BUPROPION HYDROCHLORIDE SR bupropion hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2890(NDC:50228-175)
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 K25-31
CYSTEINE HYDROCHLORIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
DEXTROSE, UNSPECIFIED FORM
ALCOHOL
ACACIA
PROPYLENE GLYCOL
SILICON DIOXIDE
Product Characteristics
Color purple Score no score
Shape ROUND (biconvex) Size 11mm
Flavor Imprint Code SG;175
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2890-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205794 04/20/2018
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-2890)

Revised: 12/2022 NuCare Pharmaceuticals,Inc.

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