FDA Product

PRAVASTATIN SODIUM

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

Basic Information

Product Name

PRAVASTATIN SODIUM

FDA Product Code

72189-061

Regulatory Information

NDC Product Code

72189-061

Application Number

ANDA076341

Marketing Category

C73584

Effective Date

June 21, 2023

Territorial Authority

USA

FDA Title

PRAVASTATIN

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerDIRECT RX

DUNS Number

079254320

Active Ingredients

PRAVASTATIN SODIUM

Quantity: 40 mg in 1 1

Code: 3M8608UQ61

Class Code: ACTIB

Inactive Ingredients

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

PRAVASTATIN

Code: KXO2KT9N0G

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

CROSCARMELLOSE

Code: 029TFK992N

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