FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
33342-212
11-digit product format
333420212
Labeler code
33342
Product ID
33342-212_4bae794e-6b1f-4630-9d00-a4524fffa0b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206156
Marketing category
ANDA
Marketing start
2020-08-24
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
3 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 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
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
33342-212-07Pramipexole Dihydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE308
33342-212-12Pramipexole Dihydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE108
33342-212-12Pramipexole Dihydrochloride10 in 1 CARTONTABLET, EXTENDED RELEASE108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-212-07EA - Each33342-2124c9a9bd2-1378-40b7-97fc-16010701e93412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-212PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 3 package rows20240713_1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901541pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral TabletPSN1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901546pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral TabletPSN1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901550pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral TabletPSN1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
1114479pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral TabletPSN1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901555pramipexole dihydrochloride 3 MG 24HR Extended Release Oral TabletPSN1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
1114485pramipexole dihydrochloride 3.75 MG 24HR Extended Release Oral TabletPSN1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901534pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral TabletPSN1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
90154124 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral TabletSCD1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
90154624 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral TabletSCD1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
90155024 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral TabletSCD1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
111447924 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral TabletSCD1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
90155524 HR pramipexole dihydrochloride 3 MG Extended Release Oral TabletSCD1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
111448524 HR pramipexole dihydrochloride 3.75 MG Extended Release Oral TabletSCD1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
90153424 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral TabletSCD1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901541pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral TabletSY1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901546pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral TabletSY1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901550pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral TabletSY1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
1114479pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral TabletSY1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901555pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral TabletSY1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
1114485pramipexole dihydrochloride 3.75 MG 24 HR Extended Release Oral TabletSY1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901534pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral TabletSY1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8
901546pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral TabletSY1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-212-073334202120730 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-212-07) 2020-08-240000-00-00NoNoCurrent
33342-212-123334202121210 BLISTER PACK in 1 CARTON (33342-212-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2020-08-240000-00-00NoNoCurrent