FDA.reportPublic FDA data

Pramipexole dihydrochloride

Product NDC
50090-3350
11-digit product format
500903350
Labeler code
50090
Product ID
50090-3350_5cb6bc03-0771-4e96-9519-bd6a62d86a64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202164
Marketing category
ANDA
Marketing start
2012-09-21
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
50090-3350-02023-01-30C16284748780-1f386c64a-1f5e-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. PRAMIPEXOLE DIHYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3350-0Pramipexole dihydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3350-0EA - Each50090-33501ed17c9b-92d3-47e1-b054-1ce2b485c57112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3350PRAMIPEXOLE DIHYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20200121_5d7c2fc2-279c-4723-b4ec-640220f2740e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859052pramipexole dihydrochloride 1 MG Oral TabletPSN5d7c2fc2-279c-4723-b4ec-640220f2740e3
859052pramipexole dihydrochloride 1 MG Oral TabletSCD5d7c2fc2-279c-4723-b4ec-640220f2740e3
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY5d7c2fc2-279c-4723-b4ec-640220f2740e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3350-05009033500090 TABLET in 1 BOTTLE (50090-3350-0) 90 tablet2018-01-240000-00-00NoNoCurrent