Simvastatin Tablet, Film Coated
NDC 65862-051

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65862-051?
  5. Simvastatin 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

Simvastatin is a ANDA-approved product labeled by Aurobindo Pharma Limited. Simvastatin 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 65862-051 and 8 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65862-051
Proprietary Name:
Simvastatin
Non-Proprietary Name: [1]
Simvastatin
Substance Name: [2]
Simvastatin
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]
Aurobindo Pharma Limited
Labeler Code:
65862
Product Label ID:
4724dbb4-3613-4e6a-948f-a43d34f97f06
FDA Application Number: [6]
ANDA077691
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-20-2006
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330)
PINK (C48328 - LIGHT PINK)
Shape:
ROUND (C48348)
Size(s):
5 MM
6 MM
Imprint(s):
A;15
A;01
Score:
1

Code Structure Chart

Product Details

What is NDC 65862-051?

The NDC code 65862-051 is assigned by the FDA to the product Simvastatin. This pharmaceutical product is labeled by Aurobindo Pharma Limited 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 8 different package configurations. 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?

Simvastatin 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.

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.
  • SIMVASTATIN 10 mg/1 - A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.
  • SIMVASTATIN 10 mg/1 - A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.

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

Simvastatin


Simvastatin 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. Simvastatin 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. Simvastatin 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). Simvastatin 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 simvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
[Learn More]


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]


Pioglitazone


Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Pioglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems.Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.
[Learn More]


Diabetes Medicines


What is diabetes?

Diabetes is a disease in which your blood glucose, or blood sugar, levels are too high. Glucose comes from the foods you eat. The cells of your body need glucose for energy. A hormone called insulin helps the glucose get into your cells.

With type 1 diabetes, your body does not make insulin. With type 2 diabetes,your body does not make or use insulin well. Without enough insulin, glucose can't get into your cells as quickly as usual. The glucose builds up in your blood and causes high blood sugar levels.

What are the treatments for diabetes?

Treatments for diabetes can depend on the type. Common treatments include a diabetic meal plan, regular physical activity, and medicines. Some less common treatments are weight loss surgery for either type and an artificial pancreas or pancreatic islet transplantation for some people with type 1 diabetes.

Who needs diabetes medicines?

People with type 1 diabetes need to take a diabetes medicine called insulin to control their blood sugar.

Some people with type 2 diabetes can control their blood sugar with healthy food choices and physical activity. But for others, a diabetic meal plan and physical activity are not enough. They need to take diabetes medicines.

The kind of medicine you take depends on your type of diabetes, daily schedule, medicine costs, and any other health conditions that you have. Over time, you may need to take more than one diabetes medicine.

What are the types of medicines for type 1 diabetes?

If you have type 1 diabetes, you must take insulin because your body no longer makes it. There are different types of insulin that start to work at different speeds, and the effects of each last a different length of time. Your health care provider will measure your blood glucose to decide on the type of insulin. You may need to use more than one type.

You will also need to check your blood sugar at home. Your provider will tell you how often. The results of your blood sugar testing can help you make decisions about food, physical activity, and medicines.

You can take insulin several different ways. The most common are with a needle and syringe, an insulin pen, or an insulin pump. If you use a needle and syringe or a pen, you have to take insulin several times during the day, including with meals. An insulin pump gives you small, steady doses throughout the day. Less common ways to take insulin include inhalers, injection ports, and jet injectors.

In rare cases, taking insulin alone might not be enough to manage your blood sugar. Then you would need to take another diabetes medicine.

What are the types of medicines for type 2 diabetes?

There are several different medicines for type 2 diabetes. Each works in a different way. Many of them are pills. There are also medicines that you inject under your skin, such as insulin.

Over time, you may need more than one diabetes medicine to manage your blood sugar. You might add another diabetes medicine or switch to a combination medicine. A combination medicine contains more than one type of diabetes medicine in the same pill. Some people with type 2 diabetes take both pills and injections.

Even if you don't usually take insulin, you may need it at special times, such as during pregnancy or if you are in the hospital.

What else should I know about taking medicines for diabetes?

Even if you take medicines for diabetes, you still need to eat a healthy diet, stop smoking, take your other medicines, and get regular physical activity. These will help you manage your diabetes.

It is important to make sure that you understand your diabetes treatment plan. Talk to your provider about:

  • What your target blood sugar level is
  • What to do if your blood sugar gets too low or too high
  • Whether your diabetes medicines will affect other medicines you take
  • If you will have any side effects from the diabetes medicines

You should not change or stop your diabetes medicines on your own. Talk to your provider first.

NIH: National Institute of Diabetes and Digestive and Kidney Diseases


[Learn More]


* 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".