PRAVASTATIN SODIUM

Basic Information

Product Name

PRAVASTATIN SODIUM

FDA Product Code

43063-808

Regulatory Information

NDC Product Code

43063-808

Application Number

ANDA207068

Marketing Category

C73584

Effective Date

April 20, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM OXIDE

Code: 3A3U0GI71G

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

PRAVASTATIN SODIUM

Quantity: 40 mg in 1 1

Code: 3M8608UQ61

Class Code: ACTIB

Active Moieties

PRAVASTATIN

Code: KXO2KT9N0G

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

CROSCARMELLOSE SODIUM

LACTOSE MONOHYDRATE

CELLULOSE, MICROCRYSTALLINE

MAGNESIUM OXIDE

D&C YELLOW NO. 10

FD&C BLUE NO. 1

POVIDONE

Active Moieties

PRAVASTATIN