Pramipexole Dihydrochloride

Product NDC
71335-1808
11-digit product format
713351808
Labeler code
71335
Product ID
71335-1808_e3cfdf1a-a178-4858-962f-e25901da5d3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202633
Marketing category
ANDA
Marketing start
2012-10-26
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.5 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE191217-81-9PRAMIPEXOLE DIHYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1808-17133518080190 TABLET in 1 BOTTLE (71335-1808-1) 90 tablet2021-12-29NoNoHistorical
71335-1808-27133518080230 TABLET in 1 BOTTLE (71335-1808-2) 30 tablet2021-04-19NoNoHistorical
71335-1808-37133518080360 TABLET in 1 BOTTLE (71335-1808-3) 60 tablet2021-12-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Pramipexole DihydrochlorideBryant Ranch Prepack2026-05-14HUMAN PRESCRIPTION DRUG LABEL103