What is NDC 18657-117?

18657-117 is the product NDC for HYLENEX Recombinant (hyaluronidase), Hyaluronidase (Human recombinant) 150 [USP'U]/mL injection, solution, listed with the FDA by Antares Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

HYLENEX Recombinant (Hyaluronidase).

What is the active ingredient?

Hyaluronidase (Human recombinant).

Antares Pharma, Inc., NDC labeler code 18657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for HYLENEX Recombinant?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

HYLENEX Recombinant NDC 18657-117 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)18657-117Labeler and product segments. Claims need a package NDC.

Product NDC at billing width18657-0117Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
18657-117-04	18657011704	4 BOX in 1 CARTON (18657-117-04) / 1 VIAL in 1 BOX (18657-117-02) / 1 mL in 1 VIAL (18657-117-01)Marketed from Dec 2, 2005

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): HYLENEX Recombinant
Generic name (nonproprietary): hyaluronidase
Active ingredients: Hyaluronidase (Human recombinant) — 150 [USP'U]/mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Antares Pharma, Inc.NDC labeler code 18657
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 021859
Marketing start: Dec 2, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Glycoside Hydrolases (Chemical structure)
Identifiers: Product ID 18657-117_37c02d08-e964-4065-ba96-69fe8eed5c2eSPL ID 37c02d08-e964-4065-ba96-69fe8eed5c2eSPL set ID 3023cc56-ed4b-4e87-b3a1-81b20943f658RxCUI 630936, 630939UNII 743QUY4VD8
Pharmacologic class: Endoglycosidase

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N418657011704 followed by a unit qualifier and the quantity

Package 18657-0117-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 11, 2024.

Indications (excerpt from the label)

1. Indications and Usage HYLENEX recombinant is an endoglycosidase indicated as an adjuvant in subcutaneous fluid administration for achieving hydration ( 1.1 ) to increase the dispersion and absorption of other injected drugs ( 1.2 ) in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 ) 1.1. Subcutaneous Fluid Administration HYLENEX recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2. Dispersion and Absorption of Injected Drugs HYLENEX recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. 1.3. Subcutaneous Urography HYLENEX recombinant is indicated as an adjun…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 18657-117

What is NDC 18657-117?: 18657-117 is the product NDC for HYLENEX Recombinant (hyaluronidase), Hyaluronidase (Human recombinant) 150 [USP'U]/mL injection, solution, listed with the FDA by Antares Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: HYLENEX Recombinant (Hyaluronidase).
What is the active ingredient?: Hyaluronidase (Human recombinant).
Who is the labeler?: Antares Pharma, Inc., NDC labeler code 18657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for HYLENEX Recombinant?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under BLA 021859

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 021859
Product	Strength	Form · route	Labeler	Product NDC
Hyaluronidase	Hyaluronidase (Human recombinant) 150 [USP'U]/mL	Injection, SolutionSubcutaneous	HF Acquisition Co LLC, DBA HealthFirst	51662-1555

HYLENEX Recombinant (Hyaluronidase) NDC 18657-117