Atorvastatin Calcium
NDC 70934-296

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Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 70934-296?
  4. Atorvastatin Calcium Uses
  5. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Atorvastatin Calcium is a ANDA-approved product labeled by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. Atorvastatin 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 is supplied as a product. This product entry covers the primary NDC 70934-296 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
70934-296
Proprietary Name:
Atorvastatin Calcium
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Denton Pharma, Inc. Dba Northwind Pharmaceuticals
Labeler Code:
70934
FDA Application Number: [6]
ANDA076477
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-01-2011
End Marketing Date: [10]
08-31-2021
Listing Expiration Date: [11]
08-31-2021
Exclude Flag: [12]
D

Code Structure Chart

Patient Education

Atorvastatin


Atorvastatin 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. Atorvastatin is also used to decrease 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. Atorvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Atorvastatin 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 atorvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
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Statins


What is cholesterol?

Cholesterol is a waxy, fat-like substance that that's found in all the cells in your body. Your body needs some cholesterol to work properly. But if you have too much of it in your blood, it can stick to the walls of your arteries and narrow or even block them. This puts you at risk for coronary artery disease and other heart diseases.

Cholesterol is made by your liver. It travels through the blood on proteins called lipoproteins. One type of lipoprotein, LDL, is sometimes called the "bad" cholesterol. A high LDL level leads to a buildup of cholesterol in your arteries. Another type, HDL, is sometimes called the "good" cholesterol. It carries cholesterol from other parts of your body back to your liver. Then your liver removes the cholesterol from your body.

What are statins?

Statins are a type of cholesterol medicine. Your health care provider may prescribe them if you have high cholesterol and making lifestyle changes does not lower your cholesterol enough. Statins are the most common medicines used to treat high cholesterol.

How do statins lower cholesterol?

Statins lower LDL cholesterol by slowing down how much cholesterol the liver makes. They also increase your liver's ability to remove LDL cholesterol that is already in the blood. This can slow the formation of plaques in your arteries. Studies have shown that statins lower the risk of heart attack and stroke in people with high LDL cholesterol.

Statins can lower your triglyceride level as well. Triglycerides are another type of fat in your blood that can raise the risk of heart disease. Statins may also increase your HDL cholesterol.

What are the risks of taking statins?

Statins usually don't cause side effects, but they may raise the risk of type 2 diabetes. However, this mainly happens in people already at high risk of diabetes, such as those who are overweight or have obesity, prediabetes, or metabolic syndrome.

Statins may also cause abnormal results on liver enzymes tests, but actual liver damage is very rare. Another uncommon side effect is muscle damage. In rare cases, this muscle damage can lead to muscle pain and kidney damage.

You should not take statins if you are pregnant or breastfeeding. They are also not recommended for people who have certain types of liver disease.

How can I safely take statins?

To safely take statins, you should:

  • Take your statin as prescribed. You should not stop taking this medicine on your own, since that can lead to a serious problem or, in rare cases, even cause death. Talk to your provider if you have any concerns about your statin or if you would like to stop or change to a different treatment.
  • Ask your provider which other medicines, supplements, or foods you should avoid. Some of these can interact with statins and cause serious side effects or make statins less effective. For example, grapefruit (fresh or as juice) affects how your liver breaks down some statins.
  • Tell your provider about any symptoms or side effects you are having. Sometimes, people report muscle problems while taking statins. If you start having muscle pain, your provider may order a blood test to look look for muscle damage. The pain may go away if you switch to a different statin. Muscle damage with statins is rare, and your muscles may heal when you switch to a different medicine.

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".