Pramipexole Dihydrochloride

Product NDC
10370-255
11-digit product format
103700255
Labeler code
10370
Product ID
10370-255_89ff8b40-dd12-40e1-a6e9-ea582f693aa1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, 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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-255-111037002551130 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-255-11) 2016-07-050000-00-00NoNoCurrent