FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
69680-146
11-digit product format
696800146
Labeler code
69680
Product ID
69680-146_232ae12c-b9bc-4ca7-982e-d6f43b6c8eec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Vitruvias Therapeutics, Inc.
Application
ANDA212797
Marketing category
ANDA
Marketing start
2021-08-27
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.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 DIHYDROCHLORIDE.75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui901541, 901546

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
69680-146-30Pramipexole Dihydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69680-146PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE [VITRUVIAS THERAPEUTICS, INC.]4Current NDC, Legacy NDC, 1 package rows20240725_d07aad1b-e078-4fca-8386-ca2e8e899688.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901541pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral TabletPSNd07aad1b-e078-4fca-8386-ca2e8e8996884
901546pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral TabletPSNd07aad1b-e078-4fca-8386-ca2e8e8996884
90154124 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral TabletSCDd07aad1b-e078-4fca-8386-ca2e8e8996884
90154624 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral TabletSCDd07aad1b-e078-4fca-8386-ca2e8e8996884
901541pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral TabletSYd07aad1b-e078-4fca-8386-ca2e8e8996884
901546pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral TabletSYd07aad1b-e078-4fca-8386-ca2e8e8996884
901546pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral TabletSYd07aad1b-e078-4fca-8386-ca2e8e8996884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69680-146-306968001463030 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-146-30) 2021-08-270000-00-00NoNoCurrent