Pramipexole Dihydrochloride
These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
d07aad1b-e078-4fca-8386-ca2e8e899688
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2021
Manufacturers
FDA
Vitruvias Therapeutics, Inc.
DUNS: 079200795
Products 2
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 Code69680-145
Application NumberANDA212797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2021
FDA Product Classification
INGREDIENTS (6)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.375 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Pramipexole Dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69680-146
Application NumberANDA212797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pramipexole Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2021
FDA Product Classification
INGREDIENTS (6)
PRAMIPEXOLE DIHYDROCHLORIDEActive
Quantity: 0.75 mg in 1 1
Code: 3D867NP06J
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT