Pramipexole dihydrochloride

Product NDC
63629-8105
11-digit product format
636298105
Labeler code
63629
Product ID
63629-8105_fb1ca73f-eb99-4682-8939-316414003fb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202164
Marketing category
ANDA
Marketing start
2012-09-21
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8105-16362981050190 TABLET in 1 BOTTLE (63629-8105-1) 90 tablet2019-07-180000-00-00NoNoCurrent