Pramipexole Dihydrochloride

Product NDC
68382-874
11-digit product format
683820874
Labeler code
68382
Product ID
68382-874_4c93c76b-c6af-4d4c-b8b6-c5bc60829ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA202891
Marketing category
ANDA
Marketing start
2018-04-24
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-874-066838208740630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-874-06) 2018-04-240000-00-00NoNoCurrent