NDC Package 18657-117-04 Hylenex Recombinant

Hyaluronidase Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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:
Proprietary Name:
Hylenex Recombinant
Non-Proprietary Name:
Hyaluronidase
Substance Name:
Hyaluronidase (human Recombinant)
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.
11-Digit NDC Billing Format:
18657011704
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Antares Pharma, Inc.
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Sample Package:
    No
    FDA Application Number:
    BLA021859
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-02-2005
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 18657-117-04 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    18657011704J3473Hyaluronidase recombinant1 USP UNIT14150600

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 18657-117-04?

    The NDC Packaged Code 18657-117-04 is assigned to a 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.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 18657-117 included in the NDC Directory?

    Yes, Hylenex Recombinant with product code 18657-117 is active and included in the NDC Directory. The product was first marketed by Antares Pharma, Inc. on December 02, 2005 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 18657-117-04?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 18657-117-04?

    The 11-digit format is 18657011704. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-218657-117-045-4-218657-0117-04