PRAVASTATIN SODIUM
Initial U.S. Approval: 1991
Approved
Approval ID
e9c188f7-cd6f-afac-b493-36552d86589e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Quallent
DUNS: 815564528
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PRAVASTATIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-006
Application NumberANDA076341
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
PRAVASTATIN SODIUMActive
Quantity: 20 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PRAVASTATIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-007
Application NumberANDA076341
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (7)
PRAVASTATIN SODIUMActive
Quantity: 40 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PRAVASTATIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-008
Application NumberANDA076341
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PRAVASTATIN SODIUMActive
Quantity: 80 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT