Bupropion Hydrochloride

Product NDC
50228-145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals,Inc.
Application
ANDA207479
Marketing category
ANDA
Substance
BUPROPION HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
50228-145-05500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-05) 2017-04-12NoHistorical
50228-145-3030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-30) 2017-04-12NoHistorical
50228-145-9090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-90) 2017-04-12NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
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 (XL), for oral use Initial U.S. Approval: 1985REMEDYREPACK INC.2026-04-15HUMAN PRESCRIPTION DRUG LABEL6
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 (XL), for oral use Initial U.S. Approval: 1985Bryant Ranch Prepack2026-04-09HUMAN PRESCRIPTION DRUG LABEL105
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 (XL), for oral use Initial U.S. Approval: 1985Bryant Ranch Prepack2026-04-08HUMAN PRESCRIPTION DRUG LABEL104
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 (XL), for oral use Initial U.S. Approval: 1985Bryant Ranch Prepack2026-03-31HUMAN PRESCRIPTION DRUG LABEL101
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 (XL), for oral use Initial U.S. Approval: 1985ScieGen Pharmaceuticals,Inc. | ScieGen Pharmaceuticals,Inc2026-02-02HUMAN PRESCRIPTION DRUG LABEL11
Bupropion HCl ER 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 (XL), for oral use Initial U.S. Approval: 1985Advanced Rx of Tennessee, LLC2025-08-29HUMAN PRESCRIPTION DRUG LABEL1
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 (XL), for oral use Initial U.S. Approval: 1985A-S Medication Solutions2024-10-16HUMAN PRESCRIPTION DRUG LABEL1
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 (XL), for oral use Initial U.S. Approval: 1985A-S Medication Solutions2024-10-16HUMAN PRESCRIPTION DRUG LABEL1
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 (XL), for oral use Initial U.S. Approval: 1985Bryant Ranch Prepack2024-07-24HUMAN PRESCRIPTION DRUG LABEL102