Pravastatin Sodium

Basic Information

Product Name

Pravastatin Sodium

FDA Product Code

54458-869

Regulatory Information

NDC Product Code

54458-869

Application Number

ANDA076056

Marketing Category

C73584

Effective Date

December 18, 2019

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

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

PRAVASTATIN SODIUM

Quantity: 20 mg in 1 1

Code: 3M8608UQ61

Class Code: ACTIB

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

Code: L11K75P92J

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

Active Moieties

PRAVASTATIN

Code: KXO2KT9N0G

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM STEARYL FUMARATE

FERRIC OXIDE YELLOW

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

CROSCARMELLOSE SODIUM

CROSPOVIDONE (15 MPA.S AT 5%)

ANHYDROUS LACTOSE

CELLULOSE, MICROCRYSTALLINE

POVIDONE K30

Active Moieties

PRAVASTATIN