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
60167d7c-469f-455a-a113-561841af5e59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2023
Manufacturers
FDA
Torrent Pharmaceuticals Limited
DUNS: 916488547
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 Code13668-093
Application NumberANDA090865
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 5, 2022
Generic NamePramipexole Dihydrochloride
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code13668-095
Application NumberANDA090865
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 5, 2022
Generic NamePramipexole Dihydrochloride
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code13668-094
Application NumberANDA090865
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 5, 2022
Generic NamePramipexole Dihydrochloride
INGREDIENTS (7)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code13668-184
Application NumberANDA090865
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 5, 2022
Generic NamePramipexole Dihydrochloride
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.75 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code13668-091
Application NumberANDA090865
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 5, 2022
Generic NamePramipexole Dihydrochloride
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.125 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
Pramipexole Dihydrochloride
PRODUCT DETAILS
NDC Product Code13668-092
Application NumberANDA090865
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 5, 2022
Generic NamePramipexole Dihydrochloride
INGREDIENTS (8)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.25 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB