Pramipexole Dihydrochloride

Product NDC
60429-089
11-digit product format
604290089
Labeler code
60429
Product ID
60429-089_494fcbc6-e427-a591-e063-6394a90ae5df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA203855
Marketing category
ANDA
Marketing start
2014-10-28
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 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

Additional Listing Data#

Finished product
Yes
Brand name base
Pramipexole Dihydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui858625, 859033, 859040, 859044, 859048, 859052

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-089-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-089-90EA - Each60429-08943583c72-3b6a-4b79-8c22-3e2e3b1e66de12015-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-089PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]14Current NDC, Legacy NDC, 1 package rows20250509_f8ac759f-59fb-49e4-a772-4114facdaea3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-089-906042900899090 TABLET in 1 BOTTLE (60429-089-90) 90 tablet2025-04-070000-00-00NoNoCurrent