Apidra Injection, Solution
NDC Package 0088-2500-34

11-digit billing NDC: 00088250034
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Apidra (insulin glulisine) injection is aPIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. This formulation utilizes a injection, solution delivery system. Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0088-2500 and is authorized under FDA application BLA021629.

Identification & Billing

NDC Package Code
0088-2500-34
Package Description
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS
Product Code
0088-2500
11-Digit Billing Format
00088250034
RxNorm Crosswalk
  • RxCUI: 485210 - insulin glulisine 100 UNT/ML Injectable Solution
  • RxCUI: 485210 - insulin glulisine, human 100 UNT/ML Injectable Solution
  • RxCUI: 485210 - insulin analog, glulisine 100 UNT/ML Injectable Solution
  • RxCUI: 803194 - Apidra 100 UNT/ML Injectable Solution
  • RxCUI: 803194 - insulin glulisine, human 100 UNT/ML Injectable Solution [Apidra]

Clinical Specifications

Proprietary Name
Apidra
Non-Proprietary Name
Insulin Glulisine
Substance Name
Insulin Glulisine
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
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
INSULIN GLULISINE 100 [iU]/mL
Pharmacologic Class
Usage Information
APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Regulatory & Marketing

Labeler Name
Sanofi-aventis U.s. Llc
Product Type
Human Prescription Drug
FDA Application #
BLA021629
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-24-2009
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 (0088-2500). Click a package code to view its specific billing and regulatory data.

0088-2500-33
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS

* 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 0088-2500-34 identifies a specific commercial package of 1 vial, glass in 1 carton / 10 ml in 1 vial, glass of Apidra, a human prescription drug labeled by Sanofi-aventis U.s. Llc. This injection, solution is formulated for intravenous; subcutaneous use and contains insulin glulisine 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 February 24, 2009. The current certification is valid through December 31, 2026.

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: 00088250034. 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)
0088-2500-34
11-Digit CMS (5-4-2)
00088-2500-34

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