FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
65862-609
11-digit product format
658620609
Labeler code
65862
Product ID
65862-609_1e01cf5f-29b7-40ce-8c46-40f8dc65ce3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202633
Marketing category
ANDA
Marketing start
2012-10-26
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1.5 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 DIHYDROCHLORIDE1.5 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
65862-609-10Pramipexole Dihydrochloride10 in 1 BLISTER PACKTABLET1015
65862-609-78Pramipexole Dihydrochloride10 in 1 CARTONTABLET1015
65862-609-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9015
65862-609-99Pramipexole Dihydrochloride1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-609-90EA - Each65862-609bdcfe417-f20e-4c27-8845-b72a3bb91e9112013-09-04
65862-609-99EA - Each65862-60912960f73-277f-4cfa-90b6-f068df6e055012013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-609PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 4 package rows20240218_3f90971a-e005-4dd3-bb93-b09125ada3c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN3f90971a-e005-4dd3-bb93-b09125ada3c815
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN3f90971a-e005-4dd3-bb93-b09125ada3c815
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN3f90971a-e005-4dd3-bb93-b09125ada3c815
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSN3f90971a-e005-4dd3-bb93-b09125ada3c815
859052pramipexole dihydrochloride 1 MG Oral TabletPSN3f90971a-e005-4dd3-bb93-b09125ada3c815
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN3f90971a-e005-4dd3-bb93-b09125ada3c815
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD3f90971a-e005-4dd3-bb93-b09125ada3c815
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD3f90971a-e005-4dd3-bb93-b09125ada3c815
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD3f90971a-e005-4dd3-bb93-b09125ada3c815
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCD3f90971a-e005-4dd3-bb93-b09125ada3c815
859052pramipexole dihydrochloride 1 MG Oral TabletSCD3f90971a-e005-4dd3-bb93-b09125ada3c815
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD3f90971a-e005-4dd3-bb93-b09125ada3c815
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY3f90971a-e005-4dd3-bb93-b09125ada3c815
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY3f90971a-e005-4dd3-bb93-b09125ada3c815
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY3f90971a-e005-4dd3-bb93-b09125ada3c815
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSY3f90971a-e005-4dd3-bb93-b09125ada3c815
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY3f90971a-e005-4dd3-bb93-b09125ada3c815
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY3f90971a-e005-4dd3-bb93-b09125ada3c815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-609-106586206091010 in 1 BLISTER PACKHistorical
65862-609-26658620609262500 TABLET in 1 BAG (65862-609-26)2500 tablet26-OCT-12Current
65862-609-786586206097810 BLISTER PACK in 1 CARTON (65862-609-78) / 10 TABLET in 1 BLISTER PACK (65862-609-10) 10 blister pack2012-10-260000-00-00NoNoCurrent
65862-609-906586206099090 TABLET in 1 BOTTLE (65862-609-90) 90 tablet2012-10-260000-00-00NoNoCurrent
65862-609-99658620609991000 TABLET in 1 BOTTLE (65862-609-99) 1000 tablet2012-10-260000-00-00NoNoCurrent