FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
71335-1504
11-digit product format
713351504
Labeler code
71335
Product ID
71335-1504_64eb3f5d-aebf-41e1-b46a-7f8880b8ca19
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
1.5 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 DIHYDROCHLORIDE1.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859048

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
71335-1504-12024-05-20C16284748780-11030e365-11aa-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
71335-1504-22024-05-20C16284748780-11030e365-11aa-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
71335-1504-12024-01-30C16284748780-11030e365-11aa-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
71335-1504-22024-01-30C16284748780-11030e365-11aa-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
71335-1504-1Pramipexole Dihydrochloride30 in 1 BOTTLETABLET305
71335-1504-2Pramipexole Dihydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1504PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 2 package rows20240522_422b27af-5e7d-4fe1-81bc-ed545c26b476.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN422b27af-5e7d-4fe1-81bc-ed545c26b4765
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD422b27af-5e7d-4fe1-81bc-ed545c26b4765
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY422b27af-5e7d-4fe1-81bc-ed545c26b4765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1504-17133515040130 TABLET in 1 BOTTLE (71335-1504-1) 30 tablet2021-12-280000-00-00NoNoCurrent
71335-1504-27133515040290 TABLET in 1 BOTTLE (71335-1504-2) 90 tablet2020-02-110000-00-00NoNoCurrent