Lantus
NDC Package 0088-5021-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Lantus is insulin glargine is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0088-5021 and is authorized under FDA application BLA021081.

Identification & Billing

NDC Package Code
0088-5021-01
Package Description
1 VIAL, GLASS in 1 PACKAGE / 10 mL in 1 VIAL, GLASS
Product Code
0088-5021
11-Digit Billing Format
00088502101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Lantus
Dosage Form
-
Usage Information
Insulin glargine is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Insulin glargine is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. Insulin glargine may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs.

Regulatory & Marketing

Labeler Name
Sanofi-aventis U.s. Llc
FDA Application #
BLA021081
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-04-2017
End Marketing Date
07-31-2024
Listing Expiration
07-31-2024
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0088-5021-01 identifies a specific commercial package of 1 vial, glass in 1 package / 10 ml in 1 vial, glass of Lantus, labeled by Sanofi-aventis U.s. Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sanofi-aventis U.s. Llc on June 04, 2017. The current certification is valid through July 31, 2024.

What are the primary indications for this medication?

Insulin glargine is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Insulin glargine is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. Insulin glargine may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs.

How is this Sanofi-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00088502101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0088-5021-01
11-Digit CMS (5-4-2)
00088-5021-01

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