Pramipexole Dihydrochloride

Basic Information

Product Name

FDA Product Code

62332-160

Regulatory Information

NDC Product Code

62332-160

Application Number

ANDA204518

Marketing Category

C73584

Effective Date

July 6, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

PRAMIPEXOLE DIHYDROCHLORIDE

Quantity: 3.75 mg in 1 1

Code: 3D867NP06J

Class Code: ACTIB

BETADEX

Code: JV039JZZ3A

Class Code: IACT

ETHYLCELLULOSE (10 MPA.S)

Code: 3DYK7UYZ62

Class Code: IACT

HYPROMELLOSE 2208 (15000 MPA.S)

Code: Z78RG6M2N2

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

PRAMIPEXOLE

Code: 83619PEU5T

Basic Information

Regulatory Information

Company Information

Active Ingredients

MICROCRYSTALLINE CELLULOSE

BETADEX

ETHYLCELLULOSE (10 MPA.S)

HYPROMELLOSE 2208 (15000 MPA.S)

MAGNESIUM STEARATE

SILICON DIOXIDE

Active Moieties

PRAMIPEXOLE