1. Home
  2. Labeler Index
  3. Ncs Healthcare Of Ky, Llc Dba Vangard Labs
  4. NDC Product Code: 0615-8539 Pravastatin Sodium

NDC 0615-8539 Pravastatin Sodium

Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0615-8539?
  5. Pravastatin Sodium Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Get all the details for National Drug Code (NDC) 0615-8539 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0615-8539
Proprietary Name:
Pravastatin Sodium
Non-Proprietary Name: [1]
Pravastatin Sodium
Substance Name: [2]
Pravastatin Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
Labeler Code:
0615
Product Label ID:
27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae
FDA Application Number: [6]
ANDA077987
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
06-01-2024
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
G5;10
Score:
1

Code Structure Chart

Product Details

What is NDC 0615-8539?

The NDC code 0615-8539 is assigned by the FDA to the product Pravastatin Sodium which is a human prescription drug product labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 0615-8539-39 30 tablet in 1 blister pack . 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 Pravastatin Sodium?

Pravastatin 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.

What are Pravastatin Sodium Active Ingredients?

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.
  • PRAVASTATIN SODIUM 10 mg/1 - An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).

Which are Pravastatin Sodium UNII Codes?

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

Which are Pravastatin Sodium 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 Pravastatin Sodium?

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:

Which are the Pharmacologic Classes for Pravastatin Sodium?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Pravastatin


Pravastatin 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. Pravastatin is also used to reduce 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. Pravastatin 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 pravastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.
[Learn More]


Statins


What is cholesterol?

Cholesterol is a waxy, fat-like substance that that's found in all the cells in your body. Your body needs some cholesterol to work properly. But if you have too much of it in your blood, it can stick to the walls of your arteries and narrow or even block them. This puts you at risk for coronary artery disease and other heart diseases.

Cholesterol is made by your liver. It travels through the blood on proteins called lipoproteins. One type of lipoprotein, LDL, is sometimes called the "bad" cholesterol. A high LDL level leads to a buildup of cholesterol in your arteries. Another type, HDL, is sometimes called the "good" cholesterol. It carries cholesterol from other parts of your body back to your liver. Then your liver removes the cholesterol from your body.

What are statins?

Statins are a type of cholesterol medicine. Your health care provider may prescribe them if you have high cholesterol and making lifestyle changes does not lower your cholesterol enough. Statins are the most common medicines used to treat high cholesterol.

How do statins lower cholesterol?

Statins lower LDL cholesterol by slowing down how much cholesterol the liver makes. They also increase your liver's ability to remove LDL cholesterol that is already in the blood. This can slow the formation of plaques in your arteries. Studies have shown that statins lower the risk of heart attack and stroke in people with high LDL cholesterol.

Statins can lower your triglyceride level as well. Triglycerides are another type of fat in your blood that can raise the risk of heart disease. Statins may also increase your HDL cholesterol.

What are the risks of taking statins?

Statins usually don't cause side effects, but they may raise the risk of type 2 diabetes. However, this mainly happens in people already at high risk of diabetes, such as those who are overweight or have obesity, prediabetes, or metabolic syndrome.

Statins may also cause abnormal results on liver enzymes tests, but actual liver damage is very rare. Another uncommon side effect is muscle damage. In rare cases, this muscle damage can lead to muscle pain and kidney damage.

You should not take statins if you are pregnant or breastfeeding. They are also not recommended for people who have certain types of liver disease.

How can I safely take statins?

To safely take statins, you should:

  • Take your statin as prescribed. You should not stop taking this medicine on your own, since that can lead to a serious problem or, in rare cases, even cause death. Talk to your provider if you have any concerns about your statin or if you would like to stop or change to a different treatment.
  • Ask your provider which other medicines, supplements, or foods you should avoid. Some of these can interact with statins and cause serious side effects or make statins less effective. For example, grapefruit (fresh or as juice) affects how your liver breaks down some statins.
  • Tell your provider about any symptoms or side effects you are having. Sometimes, people report muscle problems while taking statins. If you start having muscle pain, your provider may order a blood test to look look for muscle damage. The pain may go away if you switch to a different statin. Muscle damage with statins is rare, and your muscles may heal when you switch to a different medicine.

[Learn More]


* Please review the disclaimer below.

Product Footnotes

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".