Mirapex

Product NDC

0597-0191

11-digit product format

005970191

Labeler code

0597

Product ID

0597-0191_9db9830c-e088-f669-99ad-611ca38ab2ab

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

pramipexole dihydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

Boehringer Ingelheim Pharmaceuticals, Inc.

Application

NDA020667

Marketing category

NDA

Marketing start

2004-01-01

Marketing end

2020-04-30

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Active strength

2 mg/1

Pharmacologic classes

Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record