Pramipexole Dihydrochloride

Product NDC
68382-196
11-digit product format
683820196
Labeler code
68382
Product ID
68382-196_8906b45d-eaeb-4e7f-9aa2-dffa89109a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078920
Marketing category
ANDA
Marketing start
2010-07-10
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
0 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-196-10EA - Each68382-1964dcd0a93-9564-484f-b898-3a6ef91d8ed012012-07-24
68382-196-16EA - Each68382-196c94f7f70-3f90-470c-9086-d143e6f61c8112012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-196-0568382019605500 TABLET in 1 BOTTLE (68382-196-05) 500 tablet2010-07-100000-00-00NoNoCurrent
68382-196-10683820196101000 TABLET in 1 BOTTLE (68382-196-10) 1000 tablet2010-07-100000-00-00NoNoCurrent
68382-196-166838201961690 TABLET in 1 BOTTLE (68382-196-16) 90 tablet2010-07-100000-00-00NoNoCurrent