Pramipexole Dihydrochloride

Product NDC
63629-5034
11-digit product format
636295034
Labeler code
63629
Product ID
63629-5034_a41fc541-969c-4928-b43a-fc129fefb900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078920
Marketing category
ANDA
Marketing start
2010-07-10
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5034-16362950340190 TABLET in 1 BOTTLE (63629-5034-1) 90 tablet2013-06-130000-00-00NoNoCurrent
63629-5034-26362950340230 TABLET in 1 BOTTLE (63629-5034-2) 30 tablet2013-07-150000-00-00NoNoCurrent
63629-5034-36362950340360 TABLET in 1 BOTTLE (63629-5034-3) 60 tablet2014-03-170000-00-00NoNoCurrent