NDC 57297-480 Simvastatin

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
57297-480
Proprietary Name:
Simvastatin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Lupin Limited
Labeler Code:
57297
Start Marketing Date: [9]
11-23-2015
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332)
PINK (C48328)
RED (C48326)
Shape:
ROUND (C48348)
OVAL (C48345)
Size(s):
7 MM
9 MM
11 MM
14 MM
Imprint(s):
LL;C01
LL;C02
LL;C03
LL;C04
Score:
1

Product Packages

NDC Code 57297-480-01

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 57297-480-02

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC Code 57297-480-03

Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 57297-480?

The NDC code 57297-480 is assigned by the FDA to the product Simvastatin which is product labeled by Lupin Limited. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 57297-480-01 30 tablet, film coated in 1 bottle , 57297-480-02 90 tablet, film coated in 1 bottle , 57297-480-03 1000 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 Simvastatin?

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.

Which are Simvastatin UNII Codes?

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

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:

What is the NDC to RxNorm Crosswalk for Simvastatin?

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.

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".