FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
46708-615
11-digit product format
467080615
Labeler code
46708
Product ID
46708-615_43b3cc2f-5e67-4440-a896-69f9be384e33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA078894
Marketing category
ANDA
Marketing start
2016-03-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pramipexole Dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE1.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859033, 859040, 859044, 859048, 859052

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
46708-615-902023-12-08C16284748780-1f386c649-f286-0266-e053-dadaa90a7c1aThese 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
46708-615-902023-01-30C16284748780-1f386c649-f286-0266-e053-dadaa90a7c1aThese 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
46708-615-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-615PRAMIPEXOLE DIHYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 1 package rows20231209_0a3ed933-ef5b-4091-8ae9-5768ae18514f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859052pramipexole dihydrochloride 1 MG Oral TabletPSN0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859052pramipexole dihydrochloride 1 MG Oral TabletSCD0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY0a3ed933-ef5b-4091-8ae9-5768ae18514f2
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY0a3ed933-ef5b-4091-8ae9-5768ae18514f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-615-904670806159090 TABLET in 1 BOTTLE (46708-615-90) 90 tablet2016-03-220000-00-00NoNoCurrent