Pravastatin Sodium Tablet
NDC Package 0615-8619-39

11-digit billing NDC: 00615861939
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Pravastatin Sodium tablets are indicated:To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). This formulation utilizes a tablet delivery system. Marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs, this product is identified by NDC 0615-8619 and is authorized under FDA application ANDA076341.

Identification & Billing

NDC Package Code
0615-8619-39
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
0615-8619
11-Digit Billing Format
00615861939
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pravastatin Sodium
Non-Proprietary Name
Pravastatin Sodium
Substance Name
Pravastatin Sodium
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PRAVASTATIN SODIUM 20 mg/1
Pharmacologic Class
Usage Information
Pravastatin sodium tablets are indicated:To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.

Regulatory & Marketing

Labeler Name
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
Product Type
Human Prescription Drug
FDA Application #
ANDA076341
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-18-2011
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0615-8619). Click a package code to view its specific billing and regulatory data.

0615-8619-05
15 TABLET in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0615-8619-39 identifies a specific commercial package of 30 tablet in 1 blister pack of Pravastatin Sodium, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. This tablet is formulated for oral use and contains pravastatin sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Ncs Healthcare Of Ky, Llc Dba Vangard Labs on July 18, 2011. The current certification is valid through December 31, 2027.

How is this Ncs Healthcare Of Ky, Llc Dba Vangard Labs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00615861939. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0615-8619-39
11-Digit CMS (5-4-2)
00615-8619-39

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.