FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
68084-793
11-digit product format
680840793
Labeler code
68084
Product ID
68084-793_8c61d729-56a1-775a-e053-2a95a90aed5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078920
Marketing category
ANDA
Marketing start
2011-05-05
Marketing end
2020-08-31
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-793-11EA - Each68084-79362890794-feea-438e-9f05-28b8990009fb12014-10-03
68084-793-21EA - Each68084-7930c1bede7-3349-44da-9c34-60ef362feb1912014-10-03
68084-793-25EA - Each68084-793b36c3556-99c3-4d6f-b66f-5018a6f732f412016-04-04
68084-793-95EA - Each68084-7934979e79a-9ca6-4387-984f-6f07b3dacc9412016-04-04