FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
63629-7384
11-digit product format
636297384
Labeler code
63629
Product ID
63629-7384_b5ffb110-b4db-4427-9ef7-f35aa52022f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090865
Marketing category
ANDA
Marketing start
2010-10-08
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7384-12020-10-12C16284748780-19d75b9d0-16b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
63629-7384-22020-10-12C16284748780-19d75b9d0-16b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
63629-7384-12020-01-31C16284748780-19d75b9d0-16b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
63629-7384-22020-01-31C16284748780-19d75b9d0-16b4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7384-16362973840130 TABLET in 1 BOTTLE (63629-7384-1) 30 tablet2017-08-310000-00-00NoNoCurrent
63629-7384-26362973840290 TABLET in 1 BOTTLE (63629-7384-2) 90 tablet2017-08-310000-00-00NoNoCurrent