FDA.reportPublic FDA data

Pramipexole dihydrochloride

Product NDC
68462-627
11-digit product format
684620627
Labeler code
68462
Product ID
68462-627_75644134-fcad-4dde-8a22-453d18472002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090781
Marketing category
ANDA
Marketing start
2016-01-31
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.75 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
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
68462-627-05Pramipexole dihydrochloride500 in 1 BOTTLETABLET50013
68462-627-90Pramipexole dihydrochloride90 in 1 BOTTLETABLET9013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-627PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 2 package rows20240104_44c336d2-01d1-4f13-bad9-549cdc3505ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859052pramipexole dihydrochloride 1 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859052pramipexole dihydrochloride 1 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-627-0568462062705500 TABLET in 1 BOTTLE (68462-627-05) 500 tablet2016-01-310000-00-00NoNoCurrent
68462-627-906846206279090 TABLET in 1 BOTTLE (68462-627-90) 90 tablet2016-01-310000-00-00NoNoCurrent