Pramipexole Dihydrochloride

Basic Information

Product Name

FDA Product Code

13668-184

Regulatory Information

NDC Product Code

13668-184

Application Number

ANDA090865

Marketing Category

C73584

Effective Date

April 5, 2022

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

PRAMIPEXOLE DIHYDROCHLORIDE

Quantity: 0.75 mg in 1 1

Code: 3D867NP06J

Class Code: ACTIB

STARCH, PREGELATINIZED CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

PRAMIPEXOLE

Code: 83619PEU5T

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

FERRIC OXIDE YELLOW

MANNITOL

SILICON DIOXIDE

POVIDONE K30

STARCH, PREGELATINIZED CORN

Active Moieties

PRAMIPEXOLE