Pramipexole Dihydrochloride

Product NDC
10370-306
11-digit product format
103700306
Labeler code
10370
Product ID
10370-306_4b42cbf3-6700-4c2d-95a2-edb74067858a
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
2023-01-31
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
4 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-306-111037003061130 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-306-11) 2016-07-052023-01-31NoNoCurrent