Rosuvastatin Tablet, Film Coated
NDC Package 51407-849-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Rosuvastatin tablets are indicated:To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor.As an adjunct to diet to: Reduce LDL-C in adults with primary hyperlipidemia.Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. This formulation utilizes a tablet, film coated delivery system. Marketed by Golden State Medical Supply, Inc., this product is identified by NDC 51407-849 and is authorized under FDA application ANDA206381.

Identification & Billing

NDC Package Code
51407-849-10
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
51407-849
11-Digit Billing Format
51407084910
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rosuvastatin
Non-Proprietary Name
Rosuvastatin
Substance Name
Rosuvastatin
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ROSUVASTATIN 10 mg/1
Pharmacologic Class
Usage Information
Rosuvastatin tablets are indicated:To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor.As an adjunct to diet to: Reduce LDL-C in adults with primary hyperlipidemia.Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.

Regulatory & Marketing

Labeler Name
Golden State Medical Supply, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206381
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-24-2019
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 (51407-849). Click a package code to view its specific billing and regulatory data.

51407-849-90
90 TABLET, FILM COATED 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 51407-849-10 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Rosuvastatin, a human prescription drug labeled by Golden State Medical Supply, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1000 billable units per package. This tablet, film coated is formulated for oral use and contains rosuvastatin 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 Golden State Medical Supply, Inc. on April 24, 2019. The current certification is valid through December 31, 2026.

How is this Golden State Medical Supply, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51407084910. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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)
51407-849-10
11-Digit CMS (5-4-2)
51407-0849-10

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