Prescription medicine
Hyaluronidase Brand names: Amphadase, Hylenex; first approved as Vitrase
Hyaluronidase (Hylenex) is a prescription medicine with an FDA approval on record since 2004. No generic is listed; pharmacies paid $53.69 per mL (Hylenex 150 units/mL vial) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the hyaluronidase FDA label on DailyMed (effective February 1, 2024, Amphastar Pharmaceuticals, Inc.); the BLA 21640 record on Drugs@FDA; every hyaluronidase label on DailyMed.
Highlights of the record
FDA label of February 1, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAmphadase ® is an endoglycosidase indicated as an adjuvant:
in subcutaneous fluid administration for achieving hydration ( 1.1 )
to increase absorption and dispersion of other injected drugs ( 1.2 )
in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 ) 1.1 Subcutaneous Fluid Administration Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydrat
Forms and strengths
Injection (solution); injection.
On the market
- Earliest approval on file
- May 5, 2004 Vitrase, Bausch And Lomb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $53.69 per mL Hylenex 150 units/mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest September 11, 2024; 12 more by firms not listed as its makers
- FAERS reports
- 1,184 through July 30, 2026
What is hyaluronidase used for?
From the label: indications and usageAmphadase ® is an endoglycosidase indicated as an adjuvant:
in subcutaneous fluid administration for achieving hydration ( 1.1 )
to increase absorption and dispersion of other injected drugs ( 1.2 )
in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 ) 1.1 Subcutaneous Fluid Administration Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispersion and Absorption of Injected Drugs Amphadase ® is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. 1.3 Subcutaneous Urography Amphadase ® is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. […]
FDA pharmacologic class: Endoglycosidase.
Source: FDA drug label (AMPHADASE), Amphastar Pharmaceuticals, Inc., effective February 1, 2024 (SPL set 8396ea96-7cb5-4e26-87a4-90bca9c3c6dd), via openFDA; the full label on DailyMed
Is there a generic for hyaluronidase (Hylenex)?
No generic hyaluronidase is approved (Drugs@FDA, October 8, 2026).
- 2004 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hyaluronidase (Hylenex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $53.69 per mL (Hylenex 150 units/mL vial), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Hylenex 150 units/mL vial (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hylenex 150 units/mL vial | Brand | $53.69 per mL | n/a | +0.6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has hyaluronidase been recalled?
The FDA's Enforcement Report lists 13 recalls naming hyaluronidase since 2013: 0 Class I (the most serious), 13 Class II, 0 Class III; 0 still ongoing. 12 of them are by firms that FDA's NDC Directory does not list as a maker of hyaluronidase and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 11, 2024 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP Deviations: Temperature excursion |
| September 12, 2019 | Class II | KRS Global Biotechnology, Inc not a listed maker | Lack of Assurance of Sterility |
| May 17, 2018 | Class II | Guardian Pharmacy Services not a listed maker | Lack of sterility assurance. |
| July 26, 2016 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility |
| June 2, 2015 | Class II | The Compounding Pharmacy of America not a listed maker | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility |
| May 15, 2015 | Class II | Montana Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection |
| October 6, 2014 | Class II | Oregon Compounding Centers, Inc. dba Creative Compounds not a listed maker | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control … |
| August 27, 2014 | Class II | Martin Avenue Pharmacy, Inc. not a listed maker | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hyaluronidase label say about other medicines?
The hyaluronidase label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name hyaluronidase. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cortisone | drug interactions | Large doses of salicylates, cortisone, adrenocorticotropic hormone (ACTH), estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect |
| Epinephrine | drug interactions | When considering the administration of any other drug with hyaluronidase, it is recommended that appropriate references first be consulted to determine the usual precautions for the use of the other drug; … |
| Furosemide | drug interactions | Furosemide, the benzodiazepines and phenytoin are incompatible with hyaluronidase |
| Lidocaine | drug interactions | Admixture stability studies have shown that 2% lidocaine with 1:100,000 or 1:200,000 epinephrine is incompatible with hyaluronidase due to the presence of sodium metabisulfite, a common additive in anesthetic products containing epinephrine. |
| Phenytoin | drug interactions | Furosemide, the benzodiazepines and phenytoin are incompatible with hyaluronidase |
Other labels that name hyaluronidase
Source: FDA drug label (AMPHADASE), Amphastar Pharmaceuticals, Inc., effective February 1, 2024 (SPL set 8396ea96-7cb5-4e26-87a4-90bca9c3c6dd), via openFDA; the full label on DailyMed
What do FAERS reports show for hyaluronidase?
The FDA Adverse Event Reporting System holds 1,184 reports that list hyaluronidase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 523 are coded as a death and 690 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other endoglycosidases
- the pharmacologic class, with prices and generics
- Hyaluronidase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other