Basic Information
Bupropion hydrochloride
63304-724
Regulatory Information
63304-724
ANDA203650
C73584
February 20, 2023
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
11
Company Information
146974886
Active Ingredients
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Code: 9XZ8H6N6OH
Class Code: IACT
ETHYLCELLULOSE, UNSPECIFIED
Code: 7Z8S9VYZ4B
Class Code: IACT
GLYCERYL DIBEHENATE
Code: R8WTH25YS2
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
POVIDONE, UNSPECIFIED
Code: FZ989GH94E
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
Active Moieties
BUPROPION
Code: 01ZG3TPX31