Quick answers
- What is HYLENEX Recombinant?
- HYLENEX Recombinant is a brand name of Hyaluronidase (hyaluronidase (human recombinant)), a prescription medicine. The FDA NDC Directory lists 1 HYLENEX Recombinant product in 1 strength and form.
- Who makes HYLENEX Recombinant?
- Halozyme Therap holds the FDA application for HYLENEX Recombinant (BLA021859, approved December 2, 2005).
- Is there a generic or store brand of HYLENEX Recombinant?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a HYLENEX Recombinant product. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for HYLENEX Recombinant?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 HYLENEX Recombinant strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has HYLENEX Recombinant been recalled?
- FDA enforcement reports list 1 recall of HYLENEX Recombinant products; the newest started September 11, 2024. A recall usually concerns specific lots, not every product.
What HYLENEX Recombinant is
Each HYLENEX Recombinant product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Hyaluronidase (hyaluronidase (human recombinant)) · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| hyaluronidase (human recombinant) 150 USP units/mL injection, solution (subcutaneous) | HYLENEX Recombinant | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Hyaluronidase (hyaluronidase (human recombinant)) →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA021859 | Halozyme Therap | December 2, 2005 | 1 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hyaluronidase (human recombinant) 150 USP units/mL injection, solution | Brand: HYLENEX Recombinant | $53.58 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list HYLENEX Recombinant
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of HYLENEX Recombinant products.
- Antares Pharma, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 11, 2024 · Class II · Terminated · D-0116-2025
cGMP Deviations: Temperature excursion
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares — Mckesson Medical-Surgical Inc. Corporate Office
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.