Basic Information
Bupropion Hydrochloride
50268-141
Regulatory Information
50268-141
ANDA077284
C73584
January 9, 2024
USA
BuPROPion Hydrochloride Extended-Release Tablets USP Rx Only 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, USP for oral use Initial U.S. Approval: 1985
HUMAN PRESCRIPTION DRUG LABEL
10
Company Information
832926666
Active Ingredients
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
ETHYLCELLULOSES
Code: 7Z8S9VYZ4B
Class Code: IACT
HYDROCHLORIC ACID
Code: QTT17582CB
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
POVIDONE
Code: FZ989GH94E
Class Code: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Code: RFW2ET671P
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
HYDROGENATED COTTONSEED OIL
Code: Z82Y2C65EA
Class Code: IACT
Active Moieties
BUPROPION
Code: 01ZG3TPX31