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
0a3ed933-ef5b-4091-8ae9-5768ae18514f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 5
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 Code46708-612
Application NumberANDA078894
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (7)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.25 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-615
Application NumberANDA078894
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-614
Application NumberANDA078894
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (7)
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-611
Application NumberANDA078894
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (7)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.125 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-613
Application NumberANDA078894
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (7)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT