Quick answers
- What is Hyaluronidase used for?
- The FDA-approved label (Amphadase, Amphastar Pharmaceuticals, Inc., February 1, 2024) says: “Amphadase ® is an endoglycosidase indicated as an adjuvant: • in subcutaneous fluid administration for achieving hydration • to increase absorption and dispersion of other injected drugs • in subcutaneous urography for improving resorption of radiopaque agents 1.1 Subcutaneous Fluid Administration Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hyaluronidase have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hyaluronidase?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hyaluronidase been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Hyaluronidase?
- 1 company lists prescription products of Hyaluronidase in the FDA NDC Directory, including Amphastar Pharmaceuticals, Inc..
What Hyaluronidase is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Amphadase ® is an endoglycosidase indicated as an adjuvant: • in subcutaneous fluid administration for achieving hydration • to increase absorption and dispersion of other injected drugs • in subcutaneous urography for improving resorption of radiopaque agents 1.1 Subcutaneous Fluid Administration Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. …
— FDA label: Amphadase, Amphastar Pharmaceuticals, Inc., effective February 1, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Amphadase |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amphastar Pharmaceuticals, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA021665 AMPHADASE | Amphastar Pharm | October 26, 2004 | 5, latest August 28, 2024 2024: Labeling · 2015: Manufacturing (CMC) · 2012: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 238271, 542925 |
|---|---|
| SPL set ID of the quoted label | 8396ea96-7cb5-4e26-87a4-90bca9c3c6dd |
| FDA labels (SPL) | 1 |
| FDA applications | BLA021665 |
| Active ingredients (FDA) | HYALURONIDASE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amphadase, Amphastar Pharmaceuticals, Inc., effective February 1, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →