PRAMIPEXOLE DIHYDROCHLORIDE

Product NDC
65841-844
11-digit product format
658410844
Labeler code
65841
Product ID
65841-844_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
2022-11-23
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-844-0565841084405500 TABLET in 1 BOTTLE (65841-844-05) 500 tablet2022-11-300000-00-00NoNoCurrent
65841-844-10658410844101000 TABLET in 1 BOTTLE (65841-844-10) 1000 tablet2022-11-300000-00-00NoNoCurrent
65841-844-166584108441690 TABLET in 1 BOTTLE (65841-844-16) 90 tablet2022-11-230000-00-00NoNoCurrent