NDC 0078-0354 Lescol XL
Fluvastatin Sodium Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0078 - Novartis Pharmaceuticals Corporation
- 0078-0354 - Lescol
Product Characteristics
Product Packages
NDC Code 0078-0354-15
Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Price per Unit: $10.45088 per EA
Product Details
What is NDC 0078-0354?
What are the uses for Lescol XL?
What are Lescol XL Active Ingredients?
- FLUVASTATIN SODIUM 80 mg/1 - An indole-heptanoic acid derivative that inhibits HMG COA REDUCTASE and is used to treat HYPERCHOLESTEROLEMIA. In contrast to other statins, it does not appear to interact with other drugs that inhibit CYP3A4.
Which are Lescol XL UNII Codes?
The UNII codes for the active ingredients in this product are:
- FLUVASTATIN SODIUM (UNII: PYF7O1FV7F)
- FLUVASTATIN (UNII: 4L066368AS) (Active Moiety)
Which are Lescol XL 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:
- HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
- HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
- POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
- POVIDONE (UNII: FZ989GH94E)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for Lescol XL?
- RxCUI: 360507 - fluvastatin sodium 80 MG 24HR Extended Release Oral Tablet
- RxCUI: 360507 - 24 HR fluvastatin 80 MG Extended Release Oral Tablet
- RxCUI: 360507 - fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral Tablet
- RxCUI: 360507 - fluvastatin 80 MG 24 HR Extended Release Oral Tablet
- RxCUI: 687048 - Lescol XL 80 MG 24HR Extended Release Oral Tablet
Which are the Pharmacologic Classes for Lescol XL?
* Please review the disclaimer below.
Patient Education
Fluvastatin
Fluvastatin 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. Fluvastatin 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. Fluvastatin 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). Fluvastatin 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 fluvastatin 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".