Rosuvastatin Calcium Tablet, Film Coated
NDC 72205-002

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 72205-002?
  5. Rosuvastatin Calcium Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Rosuvastatin Calcium is a ANDA-approved product labeled by Novadoz Pharmaceuticals Llc. Rosuvastatin 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 yellow tablet, film coated for oral administration. This product entry covers the primary NDC 72205-002 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
72205-002
Proprietary Name:
Rosuvastatin Calcium
Non-Proprietary Name: [1]
Rosuvastatin Calcium
Substance Name: [2]
Rosuvastatin Calcium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Novadoz Pharmaceuticals Llc
Labeler Code:
72205
Product Label ID:
d58f1f63-4bb6-413c-9730-ded3e8078618
FDA Application Number: [6]
ANDA208898
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-22-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
R5
Score:
1

Code Structure Chart

Product Details

What is NDC 72205-002?

The NDC code 72205-002 is assigned by the FDA to the product Rosuvastatin Calcium. This pharmaceutical product is labeled by Novadoz Pharmaceuticals Llc and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 72205-002-05, 72205-002-06, 72205-002-90, 72205-002-99. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Rosuvastatin 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 to 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. Talk with your doctor for more details.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ROSUVASTATIN CALCIUM 5 mg/1 - A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Rosuvastatin


Rosuvastatin 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. Rosuvastatin is also used to decrease the amount of cholesterol 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. Rosuvastatin may also be used together with diet to decrease the amount of cholesterol and other fatty substances in the blood in adults and children and teenagers 8 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Rosuvastatin is used together with diet, and alone or in combination with other medications, to decrease the amount of cholesterol and other fatty substances in the blood in adults and children and teenagers 7 to 17 years of age who have familial homozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Rosuvastatin 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 rosuvastatin 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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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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 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".