This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

PRAMIPEXOLE DIHYDROCHLORIDE

Read time: 1 mins
Marketing start date: 18 Nov 2024
...
 

Summary of product characteristics


Effective Time

20221216

Version

9

Spl Product Data Elements

PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE D&C RED NO. 27 MAGNESIUM STEARATE MANNITOL POVIDONE STARCH, CORN SILICON DIOXIDE PINK CAPSULE P1 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE FD&C BLUE NO. 1 MAGNESIUM STEARATE MANNITOL POVIDONE STARCH, CORN SILICON DIOXIDE PALE BLUE ROUND P2 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE D&C RED NO. 27 FD&C BLUE NO. 1 MAGNESIUM STEARATE MANNITOL POVIDONE STARCH, CORN SILICON DIOXIDE LAVENDER CAPSULE P;3 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE MAGNESIUM STEARATE MANNITOL POVIDONE FERRIC OXIDE RED STARCH, CORN SILICON DIOXIDE LIGHT PEACH TO PEACH ROUND P4 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE FERRIC OXIDE YELLOW MAGNESIUM STEARATE MANNITOL POVIDONE STARCH, CORN SILICON DIOXIDE YELLOW ROUND P5 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE FERRIC OXIDE YELLOW MAGNESIUM STEARATE MANNITOL POVIDONE STARCH, CORN SILICON DIOXIDE FERRIC OXIDE RED YELLOW ROUND P5

Application Number

ANDA078920

Brand Name

PRAMIPEXOLE DIHYDROCHLORIDE

Generic Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Ndc

65841-737

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-734-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 0.125 mg Rx only 1000 tablets NDC 65841-735-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 0.25 mg Rx only 1000 tablets NDC 65841-736-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 0.5 mg Rx only 1000 tablets NDC 65841-737-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 1 mg Rx only 1000 tablets NDC 65841-738-16 in bottle of 90 tablets Pramipexole Dihydrochloride Tablets, 1.5 mg Rx only 90 tablets NDC 65841-844-16 in bottle of 90 tablets Pramipexole Dihydrochloride Tablets, 0.75 mg Rx only Pramipexole Dihydrochloride Tablets, 0.125 mg Pramipexole Dihydrochloride Tablets, 0.25 mg Pramipexole Dihydrochloride Tablets , 0.5 mg Pramipexole Dihydrochloride Tablets , 1 mg Pramipexole Dihydrochloride Tablets , 1.5 mmg 0.75 mg

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.