Soliqua 100/33 Injection, Solution
NDC Package 0024-5761-01

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

Soliqua 100/33 (insulin glargine and lixisenatide) injection is sOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This formulation utilizes a injection, solution delivery system. Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0024-5761 and is authorized under FDA application BLA208673.

Identification & Billing

NDC Package Code
0024-5761-01
Package Description
1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE
Product Code
0024-5761
11-Digit Billing Format
00024576101
RxNorm Crosswalk
  • RxCUI: 1858995 - insulin glargine 100 UNT/ML / lixisenatide 33 MCG/ML in 3 ML Pen Injector
  • RxCUI: 1858995 - 3 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen Injector
  • RxCUI: 1858995 - insulin glargine 100 UNT/ML / lixisenatide 33 MCG/ML per 3 ML Pen Injector
  • RxCUI: 1859000 - Soliqua 100/33 in 3 ML Pen Injector
  • RxCUI: 1859000 - 3 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen Injector [Soliqua]

Clinical Specifications

Proprietary Name
Soliqua 100/33
Non-Proprietary Name
Insulin Glargine And Lixisenatide
Substance Name
Insulin Glargine; Lixisenatide
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Sanofi-aventis U.s. Llc
Product Type
Human Prescription Drug
FDA Application #
BLA208673
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-21-2016
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 (0024-5761). Click a package code to view its specific billing and regulatory data.

0024-5761-05
5 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE (0024-5761-02)

* 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 0024-5761-01 identifies a specific commercial package of 1 syringe in 1 carton / 3 ml in 1 syringe of Soliqua 100/33, a human prescription drug labeled by Sanofi-aventis U.s. Llc. This injection, solution is formulated for subcutaneous use and contains insulin glargine; lixisenatide 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 Sanofi-aventis U.s. Llc on November 21, 2016. The current certification is valid through December 31, 2027.

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: 00024576101. 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)
0024-5761-01
11-Digit CMS (5-4-2)
00024-5761-01

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