FDA Product

Bupropion Hydrochloride

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

Basic Information

Product Name

Bupropion Hydrochloride

FDA Product Code

67046-076

Regulatory Information

NDC Product Code

67046-076

Application Number

ANDA075491

Marketing Category

C73584

Effective Date

August 19, 2009

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

Manufacturer

Contract Pharmacy Services-PA

DUNS Number

945429777

Active Ingredients

BUPROPION HYDROCHLORIDE

Quantity: 100 mg in 1 1

Code: ZG7E5POY8O

Class Code: ACTIB

Inactive Ingredients

HYPROMELLOSE

Code: 3NXW29V3WO

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

Active Moieties

BUPROPION

Code: 01ZG3TPX31

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