Basic Information
Bupropion hydrochloride (XL)
50090-4169
Regulatory Information
50090-4169
ANDA208652
C73584
December 21, 2017
USA
These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL).BUPROPION HYDROCHLORIDE extended-release tablets, for oral useInitial U.S. Approval: 1985
HUMAN PRESCRIPTION DRUG LABEL
4
Company Information
830016429
Active Ingredients
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
POVIDONE, UNSPECIFIED
Code: FZ989GH94E
Class Code: IACT
TARTARIC ACID
Code: W4888I119H
Class Code: IACT
GLYCERYL DISTEARATE
Code: 73071MW2KM
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Code: 9XZ8H6N6OH
Class Code: IACT
ETHYLCELLULOSE, UNSPECIFIED
Code: 7Z8S9VYZ4B
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
Active Moieties
BUPROPION
Code: 01ZG3TPX31