Basic Information
Bupropion Hydrochloride SR
0591-3541
Regulatory Information
0591-3541
ANDA079095
C73584
December 25, 2022
USA
These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
HUMAN PRESCRIPTION DRUG LABEL
51
Company Information
119723554
Active Ingredients
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Code: RFW2ET671P
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
HYDROCHLORIC ACID
Code: QTT17582CB
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
Active Moieties
BUPROPION
Code: 01ZG3TPX31