Pramipexole Dihydrochloride

Product NDC
72162-2569
11-digit product format
721622569
Labeler code
72162
Product ID
72162-2569_d1b4c9db-7f4e-4a80-997f-c0d7bcbb04a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090865
Marketing category
ANDA
Marketing start
2010-10-08
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.75 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
72162-2569-97216225690990 TABLET in 1 BOTTLE (72162-2569-9) 90 tablet2025-11-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Pramipexole DihydrochlorideBryant Ranch Prepack2025-11-17HUMAN PRESCRIPTION DRUG LABEL100