Pravastatin Sodium
Pravastatin Sodium Tablets
Approved
Approval ID
44a07041-456a-4b0b-9a8a-9e1715327d33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-131
Application NumberANDA077987
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pravastatin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2009
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PRAVASTATIN SODIUMActive
Quantity: 40 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT