PRAMIPEXOLE DIHYDROCHLORIDE

Product NDC
65841-738
11-digit product format
658410738
Labeler code
65841
Product ID
65841-738_45a8b1f5-90da-46df-9f01-2f174331f3e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAMIPEXOLE DIHYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078920
Marketing category
ANDA
Marketing start
2010-07-10
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-738-0565841073805500 TABLET in 1 BOTTLE (65841-738-05) 500 tablet2010-07-100000-00-00NoNoCurrent
65841-738-10658410738101000 TABLET in 1 BOTTLE (65841-738-10) 1000 tablet2010-07-100000-00-00NoNoCurrent
65841-738-166584107381690 TABLET in 1 BOTTLE (65841-738-16) 90 tablet2010-07-100000-00-00NoNoCurrent