FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
63629-5013
11-digit product format
636295013
Labeler code
63629
Product ID
63629-5013_067d8e1a-6550-4be0-8321-3918949ff552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090865
Marketing category
ANDA
Marketing start
2010-10-08
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.25 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.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859040

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5013-12020-10-12C16284748780-19d75b9d0-16b4-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
63629-5013-22020-10-12C16284748780-19d75b9d0-16b4-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
63629-5013-32020-10-12C16284748780-19d75b9d0-16b4-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
63629-5013-12020-01-31C16284748780-19d75b9d0-16b4-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
63629-5013-22020-01-31C16284748780-19d75b9d0-16b4-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
63629-5013-32020-01-31C16284748780-19d75b9d0-16b4-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
63629-5013-1Pramipexole Dihydrochloride90 in 1 BOTTLETABLET901012
63629-5013-2Pramipexole Dihydrochloride30 in 1 BOTTLETABLET301012
63629-5013-3Pramipexole Dihydrochloride60 in 1 BOTTLETABLET601012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5013PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1011Current NDC, Legacy NDC, 3 package rows20240912_dd4b4e2a-97b5-417d-bb90-bec692dc359b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSNdd4b4e2a-97b5-417d-bb90-bec692dc359b1012
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCDdd4b4e2a-97b5-417d-bb90-bec692dc359b1012
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSYdd4b4e2a-97b5-417d-bb90-bec692dc359b1012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5013-16362950130190 TABLET in 1 BOTTLE (63629-5013-1) 90 tablet2013-05-220000-00-00NoNoCurrent
63629-5013-26362950130230 TABLET in 1 BOTTLE (63629-5013-2) 30 tablet2013-07-160000-00-00NoNoCurrent
63629-5013-36362950130360 TABLET in 1 BOTTLE (63629-5013-3) 60 tablet2024-09-050000-00-00NoNoCurrent