PRAMIPEXOLE DIHYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS
Approved
Approval ID
0ac104bc-8ee9-4602-b1b3-38521342f97c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code65841-735
Application NumberANDA078920
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2022
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.25 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-738
Application NumberANDA078920
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2022
FDA Product Classification
INGREDIENTS (7)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-844
Application NumberANDA078920
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2022
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.75 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-734
Application NumberANDA078920
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2022
FDA Product Classification
INGREDIENTS (7)
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.125 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-737
Application NumberANDA078920
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2022
FDA Product Classification
INGREDIENTS (7)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-736
Application NumberANDA078920
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2022
FDA Product Classification
INGREDIENTS (8)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT