NDC 54458-867 Pravastatin Sodium

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54458-867
Proprietary Name:
Pravastatin Sodium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
International Laboratories, Llc
Labeler Code:
54458
Start Marketing Date: [9]
05-01-2015
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT-YELLOW)
GREEN (C48329 - LIGHT-GREEN)
Shape:
ROUND (C48348)
Size(s):
8 MM
10 MM
Imprint(s):
TEVA;7201
TEVA;7202
Score:
1

Product Packages

NDC Code 54458-867-10

Package Description: 30 TABLET in 1 BLISTER PACK

Price per Unit: $0.13040 per EA

Product Details

What is NDC 54458-867?

The NDC code 54458-867 is assigned by the FDA to the product Pravastatin Sodium which is product labeled by International Laboratories, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54458-867-10 30 tablet in 1 blister pack . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Pravastatin Sodium?

Pravastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

Which are Pravastatin Sodium UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Pravastatin Sodium Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Pravastatin Sodium?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Pravastatin


Pravastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Pravastatin is also used to reduce the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') in the blood. Pravastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with pravastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
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Statins


Statins are drugs used to lower cholesterol. Your body needs some cholesterol to work properly. But if you have too much in your blood, it can stick to the walls of your arteries and narrow or even block them.

If diet and exercise don't reduce your cholesterol levels, you may need to take cholesterol medicine. Often, this medicine is a statin. Statins interfere with the production of cholesterol in your liver. They lower LDL (bad) cholesterol levels and raise HDL (good) cholesterol levels. This can slow the formation of plaques in your arteries.

Statins are relatively safe for most people. But they are not recommended for pregnant patients or those with active or chronic liver disease. They can also cause serious muscle problems. Some statins also interact adversely with other drugs. You may have fewer side effects with one statin drug than another.

Researchers are also studying the use of statins for other conditions.

Food and Drug Administration


[Learn More]


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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".