Prescription drug · BLA
HYLENEX Recombinant (hyaluronidase) NDC 18657-117
Hyaluronidase (Human recombinant) 150 [USP'U]/mL · Injection, Solution · Subcutaneous · Antares Pharma, Inc.
NDC codes
FDA NDC Directory| 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.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 021859
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N418657011704followed by a unit qualifier and the quantityPackage 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 .
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.