FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
71335-1877
11-digit product format
713351877
Labeler code
71335
Product ID
71335-1877_e360a12f-ba9a-43d4-a513-03a30f53683e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202633
Marketing category
ANDA
Marketing start
2012-10-26
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.25 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pramipexole Dihydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui859040

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
71335-1877-1Pramipexole Dihydrochloride90 in 1 BOTTLETABLET90104
71335-1877-2Pramipexole Dihydrochloride30 in 1 BOTTLETABLET30104
71335-1877-3Pramipexole Dihydrochloride60 in 1 BOTTLETABLET60104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1877PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 3 package rows20240524_7a5d1b22-179a-44ae-9545-2704414b9905.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN7a5d1b22-179a-44ae-9545-2704414b9905104
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD7a5d1b22-179a-44ae-9545-2704414b9905104
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY7a5d1b22-179a-44ae-9545-2704414b9905104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1877-17133518770190 TABLET in 1 BOTTLE (71335-1877-1) 90 tablet2021-05-280000-00-00NoNoCurrent
71335-1877-27133518770230 TABLET in 1 BOTTLE (71335-1877-2) 30 tablet2021-12-290000-00-00NoNoCurrent
71335-1877-37133518770360 TABLET in 1 BOTTLE (71335-1877-3) 60 tablet2021-12-290000-00-00NoNoCurrent