NDC 70661-004 Roszet
(rosuvastatin And Ezetimibe) Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 70661 - Althera Pharmaceuticals Llc
- 70661-004 - Roszet
Product Characteristics
10 MM
11 MM
13 MM
AL
II
77
Product Packages
NDC Code 70661-004-10
Package Description: 10 TABLET in 1 BOTTLE
NDC Code 70661-004-30
Package Description: 30 TABLET in 1 BOTTLE
NDC Code 70661-004-35
Package Description: 30 TABLET in 1 BLISTER PACK
Product Details
What is NDC 70661-004?
What are the uses for Roszet?
What are Roszet Active Ingredients?
- EZETIMIBE 10 mg/1 - An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.
- ROSUVASTATIN CALCIUM 41.7 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 Roszet UNII Codes?
The UNII codes for the active ingredients in this product are:
- ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q)
- ROSUVASTATIN (UNII: 413KH5ZJ73) (Active Moiety)
- EZETIMIBE (UNII: EOR26LQQ24)
- EZETIMIBE (UNII: EOR26LQQ24) (Active Moiety)
Which are Roszet 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:
- STARCH, CORN (UNII: O8232NY3SJ)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- MEGLUMINE (UNII: 6HG8UB2MUY)
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
- CROSPOVIDONE (UNII: 2S7830E561)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
- MANNITOL (UNII: 3OWL53L36A)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- POVIDONE (UNII: FZ989GH94E)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
What is the NDC to RxNorm Crosswalk for Roszet?
- RxCUI: 2535745 - ezetimibe 10 MG / rosuvastatin 20 MG Oral Tablet
- RxCUI: 2535745 - ezetimibe 10 MG / rosuvastatin 20 MG (as rosuvastatin calcium 20.8 MG) Oral Tablet
- RxCUI: 2535747 - ezetimibe 10 MG / rosuvastatin 5 MG Oral Tablet
- RxCUI: 2535747 - ezetimibe 10 MG / rosuvastatin 5 MG (as rosuvastatin calcium 5.2 MG) Oral Tablet
- RxCUI: 2535749 - ezetimibe 10 MG / rosuvastatin 40 MG Oral Tablet
Which are the Pharmacologic Classes for Roszet?
* Please review the disclaimer below.
Patient Education
Ezetimibe
Ezetimibe is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in the blood. It may be used alone or in combination with an HMG-CoA reductase inhibitor (statin). Ezetimibe is in a class of medications called cholesterol-lowering medications. It works by preventing the absorption of cholesterol in the intestine. Buildup of cholesterol and fats along the walls of the blood vessels (a process known as atherosclerosis) decreases blood flow, which decreases the oxygen supply to the heart, brain, and other parts of the body. Lowering blood levels of cholesterol and fats may help reduce this buildup and may decrease your chances of developing heart conditions such as angina (chest pain), strokes, and heart attacks. Results of a clinical study that compared people who took ezetimibe and simvastatin with people who took simvastatin alone found that although the group of people taking ezetimibe and simvastatin had lower amounts of cholesterol in the blood, there was no difference between the two groups in the amount of cholesterol and fat buildup on the insides of the blood vessels in the neck. It is not currently understood why the additional lowering of cholesterol levels in the blood did not lead to a greater decrease in cholesterol and fat buildup along the walls of the blood vessels in people taking ezetimibe and simvastatin. Further studies are underway to compare treatment with ezetimibe and simvastatin to treatment with simvastatin alone to see if there is a difference in the risk of developing heart disease. Talk to your doctor if you have questions about the risks and benefits of treating increased amounts of cholesterol in your blood with ezetimibe and other medications. In addition to taking a cholesterol-lowering medication, making certain changes in your daily habits can also lower your blood cholesterol levels. You should eat a diet that is low in saturated fat and cholesterol (see SPECIAL DIETARY); exercise 30 minutes on most, if not all, days; and lose weight if you are overweight.
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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 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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* 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".