Pramipexole Dihydrochloride
These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
395fee34-43dc-4840-a6b8-70d5736f9c8b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 7, 2023
Manufacturers
FDA
ScieGen Pharmaceuticals Inc
DUNS: 079391286
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-129
Application NumberANDA203855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.75 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-126
Application NumberANDA203855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.125 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-128
Application NumberANDA203855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-131
Application NumberANDA203855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-130
Application NumberANDA203855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-127
Application NumberANDA203855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.25 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT