Simvastatin Tablet, Film Coated
NDC Package 70377-005-13

11-digit billing NDC: 70377000513
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Simvastatin tablets are indicated:To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults 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 Biocon Pharma Inc,, this product is identified by NDC 70377-005 and is authorized under FDA application ANDA078034.

Identification & Billing

NDC Package Code
70377-005-13
Package Description
45 TABLET, FILM COATED in 1 BOTTLE
Product Code
70377-005
11-Digit Billing Format
70377000513
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Simvastatin
Non-Proprietary Name
Simvastatin
Substance Name
Simvastatin
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)
SIMVASTATIN 80 mg/1
Pharmacologic Class
Usage Information
Simvastatin tablets are indicated:To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.Hypertriglyceridemia.

Regulatory & Marketing

Labeler Name
Biocon Pharma Inc,
Product Type
Human Prescription Drug
FDA Application #
ANDA078034
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-17-2015
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 (70377-005). Click a package code to view its specific billing and regulatory data.

70377-005-12
30 TABLET, FILM COATED in 1 BOTTLE
70377-005-14
90 TABLET, FILM COATED in 1 BOTTLE
70377-005-15
1000 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 70377-005-13 identifies a specific commercial package of 45 tablet, film coated in 1 bottle of Simvastatin, a human prescription drug labeled by Biocon Pharma Inc,. This tablet, film coated is formulated for oral use and contains simvastatin 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 Biocon Pharma Inc, on December 17, 2015. The current certification is valid through December 31, 2026.

How is this Biocon Pharma Inc, product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70377000513. 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)
70377-005-13
11-Digit CMS (5-4-2)
70377-0005-13

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