This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Pravastatin sodium

Read time: 1 mins
Marketing start date: 21 Dec 2024
...
 

Summary of product characteristics


Effective Time

20221013

Version

10

Spl Product Data Elements

pravastatin sodium pravastatin sodium PRAVASTATIN SODIUM PRAVASTATIN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYOXYL 35 CASTOR OIL SODIUM CARBONATE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE OVAL ZC46 pravastatin sodium pravastatin sodium PRAVASTATIN SODIUM PRAVASTATIN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYOXYL 35 CASTOR OIL SODIUM CARBONATE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE OVAL ZC45 pravastatin sodium pravastatin sodium PRAVASTATIN SODIUM PRAVASTATIN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYOXYL 35 CASTOR OIL SODIUM CARBONATE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE OVAL ZC44 pravastatin sodium pravastatin sodium PRAVASTATIN SODIUM PRAVASTATIN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYOXYL 35 CASTOR OIL SODIUM CARBONATE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE OVAL ZC43

Application Number

ANDA077751

Brand Name

Pravastatin sodium

Generic Name

pravastatin sodium

Product Ndc

65841-740

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-739-05 in bottle of 500 tablets Pravastatin Sodium Tablets USP, 10 mg R x only 500 tablets NDC 65841-740-05 in bottle of 500 tablets Pravastatin Sodium Tablets USP, 20 mg R x only 500 tablets NDC 65841-741-05 in bottle of 500 tablets Pravastatin Sodium Tablets USP, 40 mg R x only 500 tablets NDC 65841-742-05 in bottle of 500 tablets Pravastatin Sodium Tablets USP, 80 mg R x only 500 tablets Pravastatin Sodium Tablets USP, 10 mg Pravastatin Sodium Tablets USP, 20 mg Pravastatin Sodium Tablets, 40 mg Pravastatin Sodium Tablets, 80 mg

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.