Pravastatin Sodium Tablet
NDC Package 72189-060-30

11-digit billing NDC: 72189006030 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Pravastatin Sodium tablets is therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. This formulation utilizes a tablet delivery system. Marketed by Direct Rx, this product is identified by NDC 72189-060 and is authorized under FDA application ANDA076341.

Identification & Billing

NDC Package Code
72189-060-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
72189-060
11-Digit Billing Format
72189006030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.1.1 Prevention of Cardiovascular DiseaseIn hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets are indicated to:reduce the risk of myocardial infarction (MI). reduce the risk of undergoing myocardial revascularization procedures. reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. In patients with clinically evident CHD, pravastatin sodium is indicated to:reduce the risk of total mortality by reducing coronary death. reduce the risk of MI. reduce the risk of undergoing myocardial revascularization procedures. reduce the risk of stroke and stroke/transient ischemic attack (TIA). slow the progression of coronary atherosclerosis. 1.2 HyperlipidemiaPravastatin sodium tablets are indicated:as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb).1 as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV). for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet. as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present: a. LDL-C remains ≥190 mg/dL orb. LDL-C remains ≥160 mg/dL and: • there is a positive family history of premature cardiovascular disease (CVD) or • two or more other CVD risk factors are present in the patient.1.3 Limitations of Use Pravastatin sodium has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Regulatory & Marketing

Labeler Name
Direct Rx
Product Type
Human Prescription Drug
FDA Application #
ANDA076341
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-11-2019
Listing Expiration
12-31-2026
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 (72189-060). Click a package code to view its specific billing and regulatory data.

72189-060-90
90 TABLET in 1 BOTTLE

* 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 72189-060-30 identifies a specific commercial package of 30 tablet in 1 bottle of Pravastatin Sodium, a human prescription drug labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Direct Rx on November 11, 2019. The current certification is valid through December 31, 2026.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189006030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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 (5-3-2)
72189-060-30
11-Digit CMS (5-4-2)
72189-0060-30

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