Pramipexole Dihydrochloride

Product NDC
70771-1331
11-digit product format
707711331
Labeler code
70771
Product ID
70771-1331_e91fa361-7045-4e19-9ee8-0d2f389a9a6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA202891
Marketing category
ANDA
Marketing start
2018-04-24
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1331-37077113310330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1331-3) 2018-04-240000-00-00NoNoCurrent