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
87fcfa73-cc3a-b318-e053-2995a90a3a79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2021
Manufacturers
FDA
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
DUNS: 080355546
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 Code70934-236
Application NumberANDA207068
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2021
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PRAVASTATIN SODIUMActive
Quantity: 40 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT