FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
42543-709
11-digit product format
425430709
Labeler code
42543
Product ID
42543-709_95e8a82c-d86b-4179-9412-981b550ba132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Vensun Pharmaceuticals, Inc.
Application
ANDA203855
Marketing category
ANDA
Marketing start
2014-10-29
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42543-709-052020-01-31C16284748780-19d75b9cf-dac0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
42543-709-102020-01-31C16284748780-19d75b9cf-dac0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
42543-709-902020-01-31C16284748780-19d75b9cf-dac0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42543-709-05Pramipexole Dihydrochloride500 in 1 BOTTLETABLET5007
42543-709-10Pramipexole Dihydrochloride1000 in 1 BOTTLETABLET10007
42543-709-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-709-90EA - Each42543-709c5619480-2673-43b5-b721-5d99c7e585d112015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]2
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-709PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]7Legacy NDC, 3 package rows20180809_2cc30954-ba71-4313-bd69-b718da254b5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN2cc30954-ba71-4313-bd69-b718da254b5a7
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN2cc30954-ba71-4313-bd69-b718da254b5a7
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN2cc30954-ba71-4313-bd69-b718da254b5a7
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSN2cc30954-ba71-4313-bd69-b718da254b5a7
859052pramipexole dihydrochloride 1 MG Oral TabletPSN2cc30954-ba71-4313-bd69-b718da254b5a7
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN2cc30954-ba71-4313-bd69-b718da254b5a7
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD2cc30954-ba71-4313-bd69-b718da254b5a7
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD2cc30954-ba71-4313-bd69-b718da254b5a7
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD2cc30954-ba71-4313-bd69-b718da254b5a7
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCD2cc30954-ba71-4313-bd69-b718da254b5a7
859052pramipexole dihydrochloride 1 MG Oral TabletSCD2cc30954-ba71-4313-bd69-b718da254b5a7
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD2cc30954-ba71-4313-bd69-b718da254b5a7
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY2cc30954-ba71-4313-bd69-b718da254b5a7
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY2cc30954-ba71-4313-bd69-b718da254b5a7
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY2cc30954-ba71-4313-bd69-b718da254b5a7
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSY2cc30954-ba71-4313-bd69-b718da254b5a7
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY2cc30954-ba71-4313-bd69-b718da254b5a7
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY2cc30954-ba71-4313-bd69-b718da254b5a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42543-709-0542543070905500 in 1 BOTTLEHistorical
42543-709-10425430709101000 in 1 BOTTLEHistorical
42543-709-904254307099090 in 1 BOTTLEHistorical