FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
71335-0584
11-digit product format
713350584
Labeler code
71335
Product ID
71335-0584_b042def2-13f3-48c8-9a05-5b56ab536372
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
.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 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0584-1Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9010
71335-0584-2Pramipexole Dihydrochloride30 in 1 BOTTLETABLET3010
71335-0584-3Pramipexole Dihydrochloride60 in 1 BOTTLETABLET6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0584-2EA - Each71335-058426aee459-e1d4-421b-b13c-1a778df6d7b312018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0584PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 3 package rows20240830_350a3f84-0f98-405f-bdae-6abbc47d48a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN350a3f84-0f98-405f-bdae-6abbc47d48a410
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD350a3f84-0f98-405f-bdae-6abbc47d48a410
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY350a3f84-0f98-405f-bdae-6abbc47d48a410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0584-17133505840190 TABLET in 1 BOTTLE (71335-0584-1) 90 tablet2018-07-020000-00-00NoNoCurrent
71335-0584-27133505840230 TABLET in 1 BOTTLE (71335-0584-2) 30 tablet2018-04-240000-00-00NoNoCurrent
71335-0584-37133505840360 TABLET in 1 BOTTLE (71335-0584-3) 60 tablet2022-05-020000-00-00NoNoCurrent