MedPath
FDA Product

Bupropion Hydrochloride SR

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Bupropion Hydrochloride SR

70518-3787

Regulatory Information

70518-3787

ANDA205794

C73584

March 29, 2024

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

3

Company Information

REMEDYREPACK INC.

829572556

Active Ingredients

COPOVIDONE K25-31

Code: D9C330MD8B

Class Code: IACT

CYSTEINE HYDROCHLORIDE

Code: ZT934N0X4W

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

ACACIA

Code: 5C5403N26O

Class Code: IACT

DEXTROSE, UNSPECIFIED FORM

Code: IY9XDZ35W2

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

BUPROPION HYDROCHLORIDE

Quantity: 100 mg in 1 1

Code: ZG7E5POY8O

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

Active Moieties

BUPROPION

Code: 01ZG3TPX31

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