FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
46708-579
11-digit product format
467080579
Labeler code
46708
Product ID
46708-579_c9aa6022-4a1b-4fd5-a7ba-04158d9b5a05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA204518
Marketing category
ANDA
Marketing start
2019-01-03
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
3.75 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 DIHYDROCHLORIDE3.75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui901534, 901541, 901546, 901550, 901555, 1114479, 1114485

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-579-30Pramipexole Dihydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-579PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 1 package rows20230202_b6935240-ee81-49ef-adad-fb900d7f5127.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901541pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral TabletPSNb6935240-ee81-49ef-adad-fb900d7f51272
901546pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral TabletPSNb6935240-ee81-49ef-adad-fb900d7f51272
901550pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral TabletPSNb6935240-ee81-49ef-adad-fb900d7f51272
1114479pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral TabletPSNb6935240-ee81-49ef-adad-fb900d7f51272
901555pramipexole dihydrochloride 3 MG 24HR Extended Release Oral TabletPSNb6935240-ee81-49ef-adad-fb900d7f51272
1114485pramipexole dihydrochloride 3.75 MG 24HR Extended Release Oral TabletPSNb6935240-ee81-49ef-adad-fb900d7f51272
901534pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral TabletPSNb6935240-ee81-49ef-adad-fb900d7f51272
90154124 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral TabletSCDb6935240-ee81-49ef-adad-fb900d7f51272
90154624 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral TabletSCDb6935240-ee81-49ef-adad-fb900d7f51272
90155024 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral TabletSCDb6935240-ee81-49ef-adad-fb900d7f51272
111447924 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral TabletSCDb6935240-ee81-49ef-adad-fb900d7f51272
90155524 HR pramipexole dihydrochloride 3 MG Extended Release Oral TabletSCDb6935240-ee81-49ef-adad-fb900d7f51272
111448524 HR pramipexole dihydrochloride 3.75 MG Extended Release Oral TabletSCDb6935240-ee81-49ef-adad-fb900d7f51272
90153424 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral TabletSCDb6935240-ee81-49ef-adad-fb900d7f51272
901541pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral TabletSYb6935240-ee81-49ef-adad-fb900d7f51272
901546pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral TabletSYb6935240-ee81-49ef-adad-fb900d7f51272
901550pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral TabletSYb6935240-ee81-49ef-adad-fb900d7f51272
1114479pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral TabletSYb6935240-ee81-49ef-adad-fb900d7f51272
901555pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral TabletSYb6935240-ee81-49ef-adad-fb900d7f51272
1114485pramipexole dihydrochloride 3.75 MG 24 HR Extended Release Oral TabletSYb6935240-ee81-49ef-adad-fb900d7f51272
901534pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral TabletSYb6935240-ee81-49ef-adad-fb900d7f51272
901546pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral TabletSYb6935240-ee81-49ef-adad-fb900d7f51272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-579-304670805793030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-579-30) 2019-01-030000-00-00NoNoCurrent