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FDA Product

Pravastatin Sodium

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Pravastatin Sodium

55154-5365

Regulatory Information

55154-5365

ANDA076056

C73584

December 17, 2022

USA

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

HUMAN PRESCRIPTION DRUG LABEL

12

Company Information

118546603

Active Ingredients

PRAVASTATIN SODIUM

Quantity: 20 mg in 1 1

Code: 3M8608UQ61

Class Code: ACTIB

Inactive Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

LACTOSE, UNSPECIFIED FORM

Code: J2B2A4N98G

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

PRAVASTATIN

Code: KXO2KT9N0G

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