NDC 68382-066 Simvastatin
Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
PINK (C48328 - PINK)
ZA20
Code Structure Chart
Product Details
What is NDC 68382-066?
What are the uses for Simvastatin?
What are Simvastatin Active Ingredients?
- 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 Simvastatin UNII Codes?
The UNII codes for the active ingredients in this product are:
- SIMVASTATIN (UNII: AGG2FN16EV)
- SIMVASTATIN (UNII: AGG2FN16EV) (Active Moiety)
Which are Simvastatin 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:
- ASCORBIC ACID (UNII: PQ6CK8PD0R)
- HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
- ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
- STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
What is the NDC to RxNorm Crosswalk for Simvastatin?
- RxCUI: 198211 - simvastatin 40 MG Oral Tablet
- RxCUI: 200345 - simvastatin 80 MG Oral Tablet
- RxCUI: 312961 - simvastatin 20 MG Oral Tablet
- RxCUI: 312962 - simvastatin 5 MG Oral Tablet
- RxCUI: 314231 - simvastatin 10 MG Oral Tablet
Which are the Pharmacologic Classes for Simvastatin?
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Patient Education
Spironolactone
Spironolactone is used to treat certain patients with hyperaldosteronism (the body produces too much aldosterone, a naturally occurring hormone); low potassium levels; heart failure; and in patients with edema (fluid retention) caused by various conditions, including liver, or kidney disease. It is also used alone or with other medications to treat high blood pressure. Spironolactone is in a class of medications called aldosterone receptor antagonists. It causes the kidneys to eliminate unneeded water and sodium from the body into the urine but reduces the loss of potassium from the body. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
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Blood Pressure Medicines
What is high blood pressure?
High blood pressure, also called hypertension, is when blood puts too much pressure against the walls of your arteries. About 1 in 3 adults have high blood pressure, usually with no symptoms. But it can cause serious problems such as stroke, heart failure, heart attack, and kidney disease.
What lifestyle changes can help lower high blood pressure?
Healthy lifestyle changes can help reduce high blood pressure:
- Losing weight
- Being physically active
- Managing stress
- Reducing sodium in your diet
- Avoiding alcohol, tobacco, and illegal drugs
- Getting enough sleep
What if lifestyle changes alone cannot lower blood pressure?
Sometimes lifestyle changes alone cannot control or lower your high blood pressure. In that case, your health care provider may prescribe blood pressure medicines.
How do blood pressure medicines work?
Blood pressure medicines work in different ways to lower blood pressure:
- Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) keep your blood vessels from narrowing as much
- Calcium channel blockers prevent calcium from entering the muscle cells of your heart and blood vessels. This allows the blood vessels to relax.
- Diuretics remove extra water and sodium (salt) from your body. This lowers the amount of fluid in your blood. Diuretics are often used with other high blood pressure medicines, sometimes in one combined pill.
- Beta blockers help your heart beat slower and with less force. This means that your heart pumps less blood through your blood vessels. Beta blockers are typically used only as a backup option or if you also have certain other conditions.
Often, two or more medicines work better than one. While taking the medicines, it is still important to keep up with your healthy lifestyle changes.
NIH: National Heart, Lung, and Blood Institute
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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.
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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
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* Please review the disclaimer below.
[1] 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.
[2] 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.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[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".