FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
63629-8289
11-digit product format
636298289
Labeler code
63629
Product ID
63629-8289_795009ab-f8bc-4d86-9933-7d2717d22c11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202633
Marketing category
ANDA
Marketing start
2012-10-26
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 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 DIHYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859052

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
63629-8289-12024-05-10C16284748780-11030e365-4ae0-111a-e063-dadaa90a10e2These 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
63629-8289-12024-01-30C16284748780-11030e365-4ae0-111a-e063-dadaa90a10e2These 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
63629-8289-1Pramipexole Dihydrochloride30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8289PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 1 package rows20240511_1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859052pramipexole dihydrochloride 1 MG Oral TabletPSN1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad4
859052pramipexole dihydrochloride 1 MG Oral TabletSCD1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad4
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8289-16362982890130 TABLET in 1 BOTTLE (63629-8289-1) 30 tablet2020-01-100000-00-00NoNoCurrent