FDA.reportPublic FDA data

Pramipexole Dihydrochloride

Product NDC
50228-130
11-digit product format
502280130
Labeler code
50228
Product ID
50228-130_14260a48-c15f-4517-9ce5-d26928b6a5f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA203855
Marketing category
ANDA
Marketing start
2014-10-29
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 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 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
50228-130-10Pramipexole Dihydrochloride1000 in 1 BOTTLETABLET100014
50228-130-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-130-10EA - Each50228-130f56ed106-f409-4ab1-9444-c22745e2897d12025-11-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]4
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]4
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-130PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]13Current NDC, Legacy NDC, 2 package rows20230108_395fee34-43dc-4840-a6b8-70d5736f9c8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN395fee34-43dc-4840-a6b8-70d5736f9c8b14
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN395fee34-43dc-4840-a6b8-70d5736f9c8b14
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN395fee34-43dc-4840-a6b8-70d5736f9c8b14
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSN395fee34-43dc-4840-a6b8-70d5736f9c8b14
859052pramipexole dihydrochloride 1 MG Oral TabletPSN395fee34-43dc-4840-a6b8-70d5736f9c8b14
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN395fee34-43dc-4840-a6b8-70d5736f9c8b14
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD395fee34-43dc-4840-a6b8-70d5736f9c8b14
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD395fee34-43dc-4840-a6b8-70d5736f9c8b14
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD395fee34-43dc-4840-a6b8-70d5736f9c8b14
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCD395fee34-43dc-4840-a6b8-70d5736f9c8b14
859052pramipexole dihydrochloride 1 MG Oral TabletSCD395fee34-43dc-4840-a6b8-70d5736f9c8b14
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD395fee34-43dc-4840-a6b8-70d5736f9c8b14
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY395fee34-43dc-4840-a6b8-70d5736f9c8b14
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY395fee34-43dc-4840-a6b8-70d5736f9c8b14
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY395fee34-43dc-4840-a6b8-70d5736f9c8b14
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSY395fee34-43dc-4840-a6b8-70d5736f9c8b14
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY395fee34-43dc-4840-a6b8-70d5736f9c8b14
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY395fee34-43dc-4840-a6b8-70d5736f9c8b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-130-10502280130101000 TABLET in 1 BOTTLE (50228-130-10) 1000 tablet2014-10-290000-00-00NoNoCurrent
50228-130-905022801309090 TABLET in 1 BOTTLE (50228-130-90) 90 tablet2014-10-290000-00-00NoNoCurrent