Pramipexole Dihydrochloride

Product NDC
50090-3280
11-digit product format
500903280
Labeler code
50090
Product ID
50090-3280_f192c472-528a-4328-ac85-1e2c27eb8c78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202633
Marketing category
ANDA
Marketing start
2012-10-26
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.25 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

Additional Listing Data#

Finished product
Yes
Brand name base
Pramipexole Dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859040, 859044

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3280-0Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3280-0EA - Each50090-32801ef38562-d35d-4c14-9267-bccb30d3745b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3280PRAMIPEXOLE DIHYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 1 package rows20240319_29b639e3-25a5-4c2f-b4ea-a119db79fe0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN29b639e3-25a5-4c2f-b4ea-a119db79fe0c24
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN29b639e3-25a5-4c2f-b4ea-a119db79fe0c24
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD29b639e3-25a5-4c2f-b4ea-a119db79fe0c24
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD29b639e3-25a5-4c2f-b4ea-a119db79fe0c24
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY29b639e3-25a5-4c2f-b4ea-a119db79fe0c24
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY29b639e3-25a5-4c2f-b4ea-a119db79fe0c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3280-05009032800090 TABLET in 1 BOTTLE (50090-3280-0) 90 tablet2017-11-270000-00-00NoNoCurrent