Pramipexole Dihydrochloride

Product NDC

42291-557

11-digit product format

422910557

Labeler code

42291

Product ID

42291-557_7e17404b-77ac-1a76-e053-2991aa0a82c9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Pramipexole

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA202206

Marketing category

ANDA

Marketing start

2016-07-05

Marketing end

0000-00-00

Substance

PRAMIPEXOLE DIHYDROCHLORIDE

Active strength

5 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record