FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
60687-581
11-digit product format
606870581
Labeler code
60687
Product ID
60687-581_4c252238-7629-b19d-e063-6294a90a4c38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090865
Marketing category
ANDA
Marketing start
2020-08-13
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859040, 859044, 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
60687-581-11Pramipexole Dihydrochloride1 in 1 BLISTER PACKTABLET15
60687-581-21Pramipexole Dihydrochloride30 in 1 BOX, UNIT-DOSETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-581PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20241004_f4d97c2e-f447-4cfe-b9d4-852323f0cfb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSNf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859052pramipexole dihydrochloride 1 MG Oral TabletPSNf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCDf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCDf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859052pramipexole dihydrochloride 1 MG Oral TabletSCDf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSYf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSYf4d97c2e-f447-4cfe-b9d4-852323f0cfb55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-581-11606870581111 in 1 BLISTER PACKHistorical
60687-581-216068705812130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-581-21) / 1 TABLET in 1 BLISTER PACK (60687-581-11) 30 blister pack2020-08-130000-00-00NoNoCurrent