Garzulys Injection, Solution
NDC Package 71288-904-10

11-digit billing NDC: 71288090410
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Garzulys (insulin aspart-fsan) injection is insulin aspart is used with a proper diet and exercise program to control high blood sugar in people with diabetes. This formulation utilizes a injection, solution delivery system. Marketed by Meitheal Pharmaceuticals Inc., this product is identified by NDC 71288-904 and is authorized under FDA application BLA761497.

Identification & Billing

NDC Package Code
71288-904-10
Package Description
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS
Product Code
71288-904
11-Digit Billing Format
71288090410
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Garzulys
Non-Proprietary Name
Insulin Aspart-fsan
Substance Name
Insulin Aspart
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 ASPART 100 [iU]/mL
Pharmacologic Class
Usage Information
Insulin aspart 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 aspart is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. Insulin aspart starts working faster and lasts for a shorter time than regular insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This medication is usually used with a medium- or long-acting insulin product.

Regulatory & Marketing

Labeler Name
Meitheal Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761497
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-24-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1817
Source: PDAC
INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS
HCPCS Dosage 50 U
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 71288-904-10 identifies a specific commercial package of 1 vial, glass in 1 carton / 10 ml in 1 vial, glass of Garzulys, a human prescription drug labeled by Meitheal Pharmaceuticals Inc.. This injection, solution is formulated for intravenous; subcutaneous use and contains insulin aspart 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 Meitheal Pharmaceuticals Inc. on July 24, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Insulin aspart 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 aspart is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. Insulin aspart starts working faster and lasts for a shorter time than regular insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This medication is usually used with a medium- or long-acting insulin product.

How is this Meitheal Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71288090410. 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)
71288-904-10
11-Digit CMS (5-4-2)
71288-0904-10

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