Bupropion Hydrochloride (XL) (Page 10 of 10)

BuPROPion-XL 150mg 24 Hour ER-Tablets

Label Image
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BUPROPION HYDROCHLORIDE (XL) bupropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-2495(NDC:0781-5528)
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, UNSPECIFIED
TARTARIC ACID
GLYCERYL DISTEARATE
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
ETHYLCELLULOSE, UNSPECIFIED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SILICON DIOXIDE
SHELLAC
ISOPROPYL ALCOHOL
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code ST;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-2495-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:53002-2495-0 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208652 01/08/2018
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-2495), REPACK (53002-2495)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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