BUPROPION HYDROCHLORIDE (Page 9 of 9)

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BUPROPION HYDROCHLORIDE bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-849(NDC:16729-443)
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
POVIDONE K90
CYSTEINE HYDROCHLORIDE
SILICON DIOXIDE
GLYCERYL DIBEHENATE
MAGNESIUM STEARATE
ETHYLCELLULOSES
POLYETHYLENE GLYCOL 1450
HYDRATED SILICA
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white (creamy-white to pale yellow) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code GS1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-849-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210497 03/16/2020
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 relabel (55700-849)

Revised: 03/2020 Quality Care Products, LLC

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