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
1123d56c-16f0-4f81-b56f-67b1f343ae1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 4
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 Code68180-488
Application NumberANDA077917
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (11)
PRAVASTATIN SODIUMActive
Quantity: 80 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PRAVASTATIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-487
Application NumberANDA077917
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (11)
PRAVASTATIN SODIUMActive
Quantity: 40 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PRAVASTATIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-486
Application NumberANDA077917
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (11)
PRAVASTATIN SODIUMActive
Quantity: 20 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
PRAVASTATIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-485
Application NumberANDA077917
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAVASTATIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (11)
PRAVASTATIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT