Pravastatin Sodium
Pravastatin Sodium
Approved
Approval ID
7f80cd52-26f7-34ed-e053-2a91aa0adf47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2019
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
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 Code61919-734
Application NumberANDA207068
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pravastatin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2019
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PRAVASTATIN SODIUMActive
Quantity: 80 mg in 1 1
Code: 3M8608UQ61
Classification: ACTIB