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
be35f51a-786a-22cc-e053-2995a90a6aad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 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 Code70934-832
Application NumberANDA077987
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pravastatin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2021
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PRAVASTATIN SODIUMActive
Quantity: 40 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB