Hylenex Recombinant Injection, Solution
NDC Package 18657-117-04

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

Package Information

Hylenex Recombinant (hyaluronidase) injection is hYLENEX recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in HYLENEX recombinant. This formulation utilizes a injection, solution delivery system. Marketed by Antares Pharma, Inc., this product is identified by NDC 18657-117 and is authorized under FDA application BLA021859.

Identification & Billing

NDC Package Code
18657-117-04
Package Description
4 BOX in 1 CARTON / 1 VIAL in 1 BOX (18657-117-02) / 1 mL in 1 VIAL (18657-117-01)
Product Code
18657-117
11-Digit Billing Format
18657011704
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 630936 - hyaluronidase, human recombinant 150 UNT in 1 ML Injection
  • RxCUI: 630936 - 1 ML hyaluronidase, human recombinant 150 UNT/ML Injection
  • RxCUI: 630936 - hyaluronidase, human recombinant 150 UNT per 1 ML Injection
  • RxCUI: 630939 - Hylenex 150 UNT in 1 ML Injection
  • RxCUI: 630939 - 1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex]

Clinical Specifications

Proprietary Name
Hylenex Recombinant
Non-Proprietary Name
Hyaluronidase
Substance Name
Hyaluronidase (human Recombinant)
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)
HYALURONIDASE (HUMAN RECOMBINANT) 150 [USP'U]/mL
Pharmacologic Class
Usage Information
HYLENEX recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in HYLENEX recombinant. A preliminary skin test for hypersensitivity to HYLENEX recombinant can be performed. The skin test is made by an intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution. A positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction. Discontinue HYLENEX recombinant if sensitization occurs.

Regulatory & Marketing

Labeler Name
Antares Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA021859
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-02-2005
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.

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.

J3473
Source: ASP
Hyaluronidase recombinant
HCPCS Dosage 1 USP UNIT
Units / Pkg 600

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 18657-117-04 identifies a specific commercial package of 4 box in 1 carton / 1 vial in 1 box (18657-117-02) / 1 ml in 1 vial (18657-117-01) of Hylenex Recombinant, a human prescription drug labeled by Antares Pharma, Inc.. This injection, solution is formulated for subcutaneous use and contains hyaluronidase (human recombinant) 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 Antares Pharma, Inc. on December 02, 2005. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 18657011704. 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 (5-3-2)
18657-117-04
11-Digit CMS (5-4-2)
18657-0117-04

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