LOVASTATIN
LOVASTATIN TABLETS USPRx Only
Approved
Approval ID
b500eba1-422a-4590-921c-569e2bca90fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2017
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LOVASTATIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-844
Application NumberANDA075551
Product Classification
M
Marketing Category
C73584
G
Generic Name
LOVASTATIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (9)
LOVASTATINActive
Quantity: 40 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LOVASTATIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-845
Application NumberANDA075551
Product Classification
M
Marketing Category
C73584
G
Generic Name
LOVASTATIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (7)
LOVASTATINActive
Quantity: 20 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LOVASTATIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-846
Application NumberANDA075551
Product Classification
M
Marketing Category
C73584
G
Generic Name
LOVASTATIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (7)
LOVASTATINActive
Quantity: 10 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT