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  4. NDC Product Code: 70771-1483 Rosuvastatin

NDC 70771-1483 Rosuvastatin

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70771-1483?
  5. Rosuvastatin Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
70771-1483
Proprietary Name:
Rosuvastatin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Zydus Lifesciences Limited
Labeler Code:
70771
Product Label ID:
460f9985-cfe3-43ca-a023-6ebf98b87880
Start Marketing Date: [9]
01-16-2020
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW)
PINK (C48328 - PINK)
ORANGE (C48331 - ORANGE)
Shape:
ROUND (C48348)
Size(s):
7 MM
9 MM
Imprint(s):
627
628
629
Score:
1

Product Packages

NDC Code 70771-1483-0

Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

NDC Code 70771-1483-1

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC Code 70771-1483-2

Package Description: 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

NDC Code 70771-1483-3

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 70771-1483-5

Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

NDC Code 70771-1483-9

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 70771-1483?

The NDC code 70771-1483 is assigned by the FDA to the product Rosuvastatin which is product labeled by Zydus Lifesciences Limited. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 70771-1483-0 1000 tablet, film coated in 1 bottle , 70771-1483-1 100 tablet, film coated in 1 bottle , 70771-1483-2 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 70771-1483-3 30 tablet, film coated in 1 bottle , 70771-1483-5 500 tablet, film coated in 1 bottle , 70771-1483-9 90 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Rosuvastatin?

Rosuvastatin calcium is contraindicated in the following conditions:  Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin calcium [see Adverse Reactions (6.1)] .  Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions (5.2)] .  Pregnancy [see Use in Specific Populations (8.1, 8.3)] .  Lactation. Limited data indicate that rosuvastatin calcium is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin calcium treatment should not breastfeed their infants [see Use in Specific Populations (8.2)] .

Which are Rosuvastatin UNII Codes?

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

Which are Rosuvastatin 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:

What is the NDC to RxNorm Crosswalk for Rosuvastatin?

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:

* Please review the disclaimer below.

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 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.
[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]


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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".