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 useInitial U.S. Approval: 1997
Approved
Approval ID
2cc30954-ba71-4313-bd69-b718da254b5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2018
Manufacturers
FDA
Vensun Pharmaceuticals, Inc.
DUNS: 078310501
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
NDC Product Code42543-705
Application NumberANDA203855
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 3, 2018
Generic NamePramipexole Dihydrochloride
INGREDIENTS (6)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.25 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code42543-708
Application NumberANDA203855
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 3, 2018
Generic NamePramipexole Dihydrochloride
INGREDIENTS (6)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code42543-707
Application NumberANDA203855
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 3, 2018
Generic NamePramipexole Dihydrochloride
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.75 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code42543-704
Application NumberANDA203855
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 3, 2018
Generic NamePramipexole Dihydrochloride
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.125 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code42543-706
Application NumberANDA203855
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 3, 2018
Generic NamePramipexole Dihydrochloride
INGREDIENTS (6)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code42543-709
Application NumberANDA203855
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 3, 2018
Generic NamePramipexole Dihydrochloride
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT