FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
71335-1808
11-digit product format
713351808
Labeler code
71335
Product ID
71335-1808_e3cfdf1a-a178-4858-962f-e25901da5d3a
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
.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 DIHYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859044

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
71335-1808-12024-05-17C16284748780-11030e365-6582-111a-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
71335-1808-22024-05-17C16284748780-11030e365-6582-111a-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
71335-1808-32024-05-17C16284748780-11030e365-6582-111a-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
71335-1808-12024-01-30C16284748780-11030e365-6582-111a-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
71335-1808-22024-01-30C16284748780-11030e365-6582-111a-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
71335-1808-32024-01-30C16284748780-11030e365-6582-111a-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
71335-1808-1Pramipexole Dihydrochloride90 in 1 BOTTLETABLET90103
71335-1808-2Pramipexole Dihydrochloride30 in 1 BOTTLETABLET30103
71335-1808-3Pramipexole Dihydrochloride60 in 1 BOTTLETABLET60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1808PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20240518_f1ff3695-33db-471d-a3db-89fbb9ed9e0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNf1ff3695-33db-471d-a3db-89fbb9ed9e0c103
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCDf1ff3695-33db-471d-a3db-89fbb9ed9e0c103
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYf1ff3695-33db-471d-a3db-89fbb9ed9e0c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1808-17133518080190 TABLET in 1 BOTTLE (71335-1808-1) 90 tablet2021-12-290000-00-00NoNoCurrent
71335-1808-27133518080230 TABLET in 1 BOTTLE (71335-1808-2) 30 tablet2021-04-190000-00-00NoNoCurrent
71335-1808-37133518080360 TABLET in 1 BOTTLE (71335-1808-3) 60 tablet2021-12-290000-00-00NoNoCurrent