FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
57237-184
11-digit product format
572370184
Labeler code
57237
Product ID
57237-184_967cfcd5-d04f-4637-a364-632bf7ca72b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202633
Marketing category
ANDA
Marketing start
2012-10-26
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 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 DIHYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D867NP06J
Rxcui858625, 859033, 859040, 859044, 859048, 859052

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
57237-184-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9011
57237-184-99Pramipexole Dihydrochloride1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-184-90EA - Each57237-184492cefca-2cb5-462c-9447-742a17da208a12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-184PRAMIPEXOLE DIHYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 2 package rows20240222_56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSN56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859052pramipexole dihydrochloride 1 MG Oral TabletPSN56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCD56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859052pramipexole dihydrochloride 1 MG Oral TabletSCD56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSY56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec11
859052pramipexole dihydrochloride 1 MG Oral TabletPSN1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad4
859052pramipexole dihydrochloride 1 MG Oral TabletSCD1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad4
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-184-905723701849090 TABLET in 1 BOTTLE (57237-184-90) 90 tablet2012-10-260000-00-00NoNoCurrent
57237-184-99572370184991000 TABLET in 1 BOTTLE (57237-184-99) 1000 tablet2012-10-260000-00-00NoNoCurrent