PRAVASTATIN SODIUM
These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
6bb60d07-0787-4d5f-8a8c-1224d5b02b2b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code63629-9162
Application NumberANDA209869
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2021
FDA Product Classification
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
PRAVASTATIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT