Which Hyaluronidase Vial Is This: Hylenex, Vitrase, or Other?

Which Hyaluronidase Vial Is This?

Read the carton and the insert in the hand, not the word hyaluronidase on a consent form. For this labeled fictional vial, mark one identity: Hylenex recombinant (human), Vitrase (ovine), Amphadase (bovine), or none of those. Hyaluronidase is an enzyme class, not one pharmaceutical carton. Worked examples below are hypothetical identity classifications. They are not a real patient, not an actual emergency-kit SKU, and not a census of what clinics stock.

Classify from the printed trade name, source wording, strength, and NDC if present. If the name, source, NDC, or insert is blank, the honest mark is unknown. Current U.S. cartons that still match one of the three licensed products look like this:

• Hylenex recombinant (human): Manufactured by Halozyme Therapeutics and distributed by Antares Pharma under BLA 021859. Produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding a soluble fragment of human hyaluronidase (PH20). Supplied at 150 USP units/mL in 1 mL single-dose glass vials (NDC 18657-117-01; cartons of 4: NDC 18657-117-04). Formulated with albumin human, nonpreserved, and marked NOT FOR IV USE and REFRIGERATE.

• Vitrase (ovine): Distributed by Bausch & Lomb under BLA 021640. Purified ovine testicular hyaluronidase. Carton wording still includes Hyaluronidase Injection Vitrase 200 USP Units/mL, two 1 mL single-dose vials, NDC 24208-002-02. DailyMed's packaging row for that NDC also lists 1.2 mL in 1 vial; record both printed fields rather than forcing one fill volume. Formulated with lactose and potassium phosphate buffers, nonpreserved, and explicitly marked on the carton as Derived from ovine testicle.

• Amphadase (bovine): Manufactured by Amphastar Pharmaceuticals under BLA 021665. Purified from bovine (cattle/cow) testicular tissue. Supplied at a concentration of 150 USP units/mL in 1 mL single-dose glass vials (NDC 0548-9090-10, cartons of 10 vials). Formulated with calcium chloride and preserved with not more than 0.1 mg of thimerosal (a mercury derivative). The carton explicitly states Derived from bovine testicle.

• None of those (compounded, discontinued, or foreign): Any unmatched carton: pharmacy-compounded or unlabeled hyaluronidase, Hydase (BLA 021716; Drugs@FDA marketing status Discontinued), a carton that actually names the discontinued Vitrase 6,200 Units/vial lyophilized presentation, or a non-U.S. name such as Liporase or Hyalase that does not appear on these three U.S. labels. Compounded and unlabeled vials do not inherit Hylenex, Vitrase, or Amphadase Indications and Usage. Discontinued status is not a leftover-vial census, and a leftover Hydase carton is still none of those three current identities.

Keep this indication mark in the worksheet: hyaluronic acid filler dissolution and vascular occlusion rescue do not appear anywhere among the FDA-approved indications for Hylenex, Vitrase, or Amphadase. Current DailyMed and FDA prescribing information for Hylenex recombinant, Vitrase, and Amphadase lists only those three adjuvant uses: subcutaneous fluid administration for hydration, increasing the dispersion and absorption of other injected drugs, and subcutaneous urography. Using a licensed hyaluronidase to dissolve hyaluronic-acid filler is an unapproved use of an approved product when that use is not among the labeled indications. Off-label legality of a physician's prescription is not an identity field that converts the carton into an FDA-approved dissolve enzyme, and it is not a dose protocol.

Vial Identity Worksheet: Name, Source, Strength, and NDC

Read the container in hand across the worksheet columns. Record each field from the outer carton and the insert inside it. If a parameter is unlisted, obscured, or absent, mark it unknown rather than assuming a commercial identity.

The following table is a labeled fictional worksheet. Rows are hypothetical identity classifications, not typical kit contents and not a finding of allergy or occlusion:

An NDC that still matches 18657-117, 24208-002, or 0548-9090 is a carton identity cross-check against DailyMed, not proof that filler dissolution is indicated. A compounded or unlabeled vial without those NDCs is none of those. DailyMed's Marketing End Date of 31 May 2024 for Vitrase NDC 24208-002-02 and Drugs@FDA's Prescription status for the 200-units/vial presentation are separate database fields; neither is a count of vials remaining in aesthetic kits.

What the current labels actually indicate

A carton in a filler emergency kit or dissolve visit is not, by that location, a product FDA-labeled to dissolve filler. Indications and Usage on the current Hylenex, Vitrase, and Amphadase labels do not list hyaluronic-acid filler dissolution or vascular-occlusion rescue.

Under the Code of Federal Regulations, specifically 21 CFR 201.57(c)(2)(v), for biological products, all indications listed in Indications and Usage must be supported by substantial evidence of effectiveness. The same paragraph states that indications or uses must not be implied or suggested in other sections of the labeling if not included in Indications and Usage.

The current prescribing information for Hylenex recombinant (BLA 021859/S-031, DailyMed revised 11/2024), Vitrase (BLA 021640/S-028), and Amphadase (BLA 021665/S-007; DailyMed Rev. 2/2024, highlights Revised 9/2024) share the same three labeled adjuvant indications:

• Subcutaneous fluid administration (hypodermoclysis): Indicated as an adjuvant in subcutaneous fluid administration for achieving hydration (hypodermoclysis on the Vitrase label).

• Dispersion and absorption of other injected drugs: Indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. That labeled adjuvant use is not a filler-dissolve indication.

• Subcutaneous urography: Indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque agents.

The Highlights header on current Hylenex labeling names infiltration, interstitial, intramuscular, intraocular, peribulbar, retrobulbar, soft-tissue, or subcutaneous use. Those are route-of-use statements, also reflected in Description, not a fourth indication. Halozyme's Hylenex.com healthcare-professional page, retrieved 15 September 2026, headlines only one of the three labeled uses—an adjuvant to increase the dispersion and absorption of other injected drugs—and states that Hylenex recombinant is the only FDA-approved recombinant human hyaluronidase. That manufacturer sentence is narrower than the FDA/DailyMed Indications and Usage list. It is a source-identity contrast with ovine Vitrase and bovine Amphadase. It is not a ranking of dissolve products and is not proof that Hylenex is FDA-approved to dissolve filler. Clinic pages that treat Dosage and Administration sentences about adding hyaluronidase to another injection solution as dissolve authorization are collapsing a labeled adjuvant use into an on-label dissolve protocol. Under 21 CFR 201.57(c)(2)(v), other labeling sections must not imply an indication missing from Indications and Usage. Soft-tissue use and dispersion of other injected drugs are therefore not a labeled indication to dissolve previously placed hyaluronic-acid filler or to rescue vascular occlusion.

According to the FDA's regulatory framework governing unapproved use of approved drugs ('off-label'), unapproved use of an approved drug includes using it for a disease or medical condition it is not approved to treat, giving it a different way, or giving it a different dose. From FDA's perspective, healthcare providers generally may prescribe an approved drug for an unapproved use when they judge that medically appropriate. FDA also states that when a drug is prescribed for its approved use, FDA has evaluated benefits and risks for that use and there is approved labeling on how to use it safely and effectively for that use. For filler dissolving, which is not among the labeled indications:

• FDA has not determined that the drug is safe and effective for that unapproved use.

• Approved labeling does not contain a filler-dissolution or vascular-occlusion dose, dilution scheme, or administration protocol.

• A clinician's ability to prescribe off-label does not convert the carton into an FDA-approved filler dissolver.

Hylenex, Vitrase, and Amphadase are different cartons

These three cartons are different identities. Unit-per-mL figures are not volume-to-volume conversion math, and they are not a ranked dissolve-brand list.

Hylenex Recombinant: Human PH20 Biologic

Hylenex recombinant (hyaluronidase human injection) is a genetically engineered biologic licensed under BLA 021859. The active ingredient is a glycosylated single-chain protein produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding a soluble fragment of human hyaluronidase (PH20), with an approximate molecular weight of 61 kDa.

Key carton and formulation characteristics include:

• Potency and packaging: Supplied as a sterile, clear, colorless solution of 150 USP units/mL in 1 mL single-dose glass vials (NDC 18657-117-01; four vials per shelf pack: NDC 18657-117-04).

• Excipient composition: Each milliliter contains albumin human 1 mg, dibasic sodium phosphate 1.4 mg, methionine 1.5 mg, polysorbate 80 0.2 mg, and sodium chloride 8.5 mg. The formulation is nonpreserved.

• Storage and handling: Unopened vials must be stored refrigerated between 2°C and 8°C (36°F to 46°F). Freezing must be avoided. The carton is marked with explicit warnings: NOT FOR IV USE and REFRIGERATE.

• Manufacturer details: Manufactured by Halozyme Therapeutics, Inc. (U.S. License No. 2187). DailyMed labeling (revised November 2024, LBL301-07) lists distribution by Antares Pharma, Inc.

Section 14 of the Hylenex package insert describes the formal clinical trials submitted to secure commercial approval. Section 14 describes an open-label multicenter single-arm study in 51 pediatric patients with mild to moderate dehydration and a prospective, randomized, double-blinded, placebo-controlled, within-subject study in 54 healthy volunteers of Lactated Ringer's infusion rate with versus without Hylenex (mean 464 mL/hr versus 118 mL/hr). Those studies support the labeled hydration adjuvant use. They are not filler-dissolution trials and are not a dissolve-dose table.

Vitrase: Ovine Testicular Biologic

Vitrase (hyaluronidase injection, ovine) is an animal-derived biologic licensed under BLA 021640 and distributed by Bausch & Lomb. Unlike recombinant human Hylenex, Vitrase is a preparation of purified ovine testicular hyaluronidase.

Clinic pages that call Vitrase bovine or porcine do not match the current carton. The outer carton states Hyaluronidase Injection Vitrase 200 USP Units/mL, Derived from ovine testicle. Distinctive formulation aspects include:

• Potency and concentration: Labeled strength is 200 USP Units/mL as a clear, colorless solution in a single-dose vial (carton NDC 24208-002-02, two vials). That is not 150 USP units/mL. Direct milliliter-to-milliliter substitution with Hylenex or Amphadase is not an identity field, and the products are not interchangeable generics.

• Excipient composition: Formulated with lactose, monobasic and dibasic potassium phosphate buffers, and sodium chloride. It is unpreserved and albumin-free.

• Storage: Must be refrigerated between 2°C and 8°C, protected from light, and protected from freezing.

• Regulatory presentations and marketing dates: Drugs@FDA, as retrieved for this worksheet, lists two presentations under BLA 021640: VITRASE 200 UNITS/VIAL, marketing status Prescription, and VITRASE 6,200 UNITS/VIAL, marketing status Discontinued. The 6,200-units/vial lyophilized presentation is a different, discontinued identity from the 200 units/mL solution. DailyMed lists Marketing End Date 31 May 2024 for NDC 24208-002-02. Record both database fields. Do not convert either field into leftover inventory.

Amphadase: Bovine Testicular Biologic

Amphadase (hyaluronidase injection) is a purified bovine testicular enzyme licensed under BLA 021665 (a former New Drug Application deemed a BLA on 23 March 2020) and manufactured by Amphastar Pharmaceuticals (U.S. License No. 2179).

Physical packaging highlights include:

• Potency and presentation: Supplied as 150 USP units/mL in 1 mL single-dose glass vials (NDC 0548-9090-10, packaged 10 single-dose vials per carton).

• Carton wording: The carton prominently displays Hyaluronidase Injection Amphadase 150 USP units/mL, Derived from bovine testicle, Not for IV use.

• Excipient and preservative profile: Each milliliter contains calcium chloride (0.4 mg), edetate disodium (1.0 mg), monobasic sodium phosphate (1.7 mg), sodium chloride (8.5 mg), Water for Injection, and not more than 0.1 mg of thimerosal.

• Clinical significance of thimerosal: Thimerosal is a mercury-derivative preservative. Its presence on the carton is an essential chemical identity marker that distinguishes Amphadase from unpreserved Hylenex and Vitrase. Hypersensitivity to hyaluronidase or any other ingredient is a labeled contraindication; thimerosal is one Amphadase ingredient. That is not a brand ranking.

Is a Skin-Test Instruction on This Insert?

Whether a hypersensitivity skin-test instruction is on that label is a label-version identity field, not a universal patch-test protocol and not a reason this page delays or gives a vascular-occlusion dose. Record present, absent, or unknown for this insert.

Current 2024 U.S. prescribing information for Hylenex (DailyMed Rev. 11/2024), Vitrase (BLA 021640/S-028), and Amphadase (DailyMed Rev. 2/2024 / S-007) does not include an optional intradermal skin-test paragraph. Current Hylenex and Vitrase section 4, and Amphadase section 4.1, state known hypersensitivity to hyaluronidase or any other ingredient/excipient as a contraindication, and to discontinue if sensitization occurs. They do not reprint the older optional skin-test paragraph.

In contrast, older historical package inserts contained explicit, optional intradermal skin-test instructions:

• Historical Amphadase labeling: FDA's 2012 Amphadase PI (NDA 21-665/S-005) stated that a preliminary skin test can be performed by intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution. A positive reaction was described as a wheal with pseudopods within 5 minutes persisting 20 to 30 minutes with localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction.

• Historical Vitrase labeling: FDA's 2018 Vitrase PI (NDA 021640/S-025) specified an optional preliminary skin test of approximately 0.02 mL (4 Units) of a 200 Units/mL solution. That unit count is not the 3-Unit / 150 Unit/mL wording on older Hylenex and Amphadase labels.

• Historical Hylenex labeling: The 2016 Hylenex PI (NDA 21859/S-023) included an optional preliminary skin test of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution, later omitted from the 2024 PI.

A leftover carton can still contain an older insert. That does not make the 2012 or 2018 paragraph current 2024 labeling, and the 2024 omission is not proof that no leftover insert still prints it. Boundaries for this worksheet:

• Those historical sentences were labeled as an optional preliminary skin test, not a requirement to patch-test before filler dissolving, and not a protocol for every hyaluronidase.

• Do not treat 0.02 mL as a universal patch test. On the older Amphadase and Hylenex wording it was approximately 3 Units of a 150 Unit/mL solution; on the older Vitrase wording it was approximately 4 Units of a 200 Units/mL solution. Those unit counts are not interchangeable.

• Recording present, absent, or unknown for this insert is not a dissolve dose, not a vascular-occlusion protocol, and not a reason to delay emergency care. If the insert is missing, the honest mark is unknown.

Compounded, Hydase, and Unlabeled Vials Are None of Those

Any vial that cannot be matched to an active Hylenex, Vitrase, or Amphadase carton falls into the residual category: none of those. It is not a fourth FDA-labeled dissolve product.

Compounded Hyaluronidase and FDA 503A Guidance

A compounded hyaluronidase vial is not a generic of Hylenex, Vitrase, or Amphadase, and it does not inherit those labels' Indications and Usage. Do not invent that a particular compound is illegal without the vial's actual label and prescription record.

Under the FDA's regulatory guidance document Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the FD&C Act (January 2018; content current as of 6 May 2020 on the FDA page), that guidance is nonbinding policy language for 503A exemptions. To qualify for 503A exemptions, a compounder must not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. FDA generally considers a compounded drug essentially a copy if it has the same API, the same, similar, or easily substitutable strength, and the same route of administration, unless a prescriber has determined that a change produces a significant difference for an identified individual patient. The guidance's four-or-fewer-prescriptions-per-month example is enforcement-discretion language, not a finding about any named clinic kit.

If the vial is compounded or unlabeled, source species, strength, NDC, insert, and labeled indications remain unknown unless they are actually printed. Calling it generic hyaluronidase or the dissolve enzyme does not fill those fields.

Discontinued Products and Foreign Imports

Other products frequently encountered in aesthetic literature or international practices include:

• Hydase (BLA 021716): Drugs@FDA lists HYDASE, hyaluronidase 150 UNITS/ML, BLA 021716, company Akorn Inc, original approval 25 October 2005, marketing status Discontinued. That marketing-status field is not a finding that no leftover Hydase carton exists. Hydase is not one of the three named worksheet buckets.

• Vitrase 6,200 Units/vial: A different identity from the 200 units/mL solution. Drugs@FDA lists the 6,200-units/vial presentation as Discontinued. If that is what the carton actually says, it is none of those current 200 USP Units/mL Vitrase cartons.

• Foreign commercial brands (Liporase, Hyalase): Those names do not appear on the current Hylenex, Vitrase, or Amphadase U.S. labels. They are unmatched identities for this worksheet, not a fourth U.S. labeled product and not a dissolve-indication finding.

• Combination biologic pharmaceuticals: Combination biologics such as HyQvia or Darzalex Faspro contain recombinant hyaluronidase as a component of a different licensed product. They are not Hylenex vials. If someone confuses the names, the worksheet mark is none of those.

Shared Contraindications and Safety Boundaries

Current Hylenex, Vitrase, and Amphadase labels share several warnings that are identity and safety-boundary fields, not dissolve instructions:

• Absolute contraindication for intravenous administration: Hyaluronidase should not be administered intravenously because the enzyme is rapidly inactivated. That labeled warning is not a vascular-occlusion injection-technique protocol.

• Contraindicated in acute local infection: Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.

• Never used for bites or stings: Hyaluronidase should not be used to reduce the swelling of bites or stings.

• Ocular and topical restrictions: Hyaluronidase should not be applied directly to the cornea. Hylenex labeling adds that it is not for topical use.

Current Hylenex and Amphadase postmarketing language states that allergic reactions (urticaria or angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase, and that anaphylactic-like reactions after retrobulbar block or intravenous injections have occurred rarely. That is labeled class postmarketing language on those two inserts, not a Hylenex-versus-Vitrase-versus-Amphadase allergy ranking and not invented product-specific rates. Thimerosal on the Amphadase carton is an identity field (not more than 0.1 mg per mL, a mercury derivative). It is not a finding that Amphadase is safer or less safe than Hylenex.

What this page does not decide

This worksheet marks what an in-hand fictional vial still is on its carton and insert. It does not decide elective dissolving, emergency-kit stocking, or vascular-occlusion treatment.

Specifically, this guide does not provide:

• A dissolve dose, dilution scheme, or ultrasound technique. Those jobs belong on other pages, not this identity worksheet.

• A vascular-occlusion treatment protocol or a ranked hyaluronidase brand list.

• A clinic inventory census, leftover-vial count, or typical mix of kit contents.

Adjacent published jobs on this site, which this page does not retell:

• When to dissolve, ultrasound, allergy, and waiting: Dissolving filler with hyaluronidase: ultrasound, allergy, and when to wait..

• How a practice stocks and drills a hyaluronidase kit: Hyaluronidase Emergency Kit for Filler Vascular Occlusion.

• Vascular-occlusion warning signs and what to ask: Filler vascular occlusion: the complication every patient should know about.

• Consent documentation for off-label aesthetic use: Off-Label Aesthetic Treatment Consent: Documenting Risk Clearly.

• Requesting notes, device settings, and lot numbers: Requesting Aesthetic Records: Device Settings, Lot Numbers, and Limits.

Sources

• U.S. National Library of Medicine DailyMed. HYLENEX RECOMBINANT (hyaluronidase) injection, solution. Current SPL version 11, updated November 11, 2024; revised November 2024. Packaged by Antares Pharma, Inc.; manufactured by Halozyme Therapeutics, Inc.

• U.S. Food and Drug Administration. HYLENEX recombinant (hyaluronidase) injection prescribing information. BLA 021859/S-031, approved January 12, 2024. Center for Drug Evaluation and Research.

• U.S. Food and Drug Administration. VITRASE (hyaluronidase injection) prescribing information. BLA 021640/S-028, approved January 12, 2024. Bausch & Lomb Incorporated.

• U.S. National Library of Medicine DailyMed. VITRASE (hyaluronidase, ovine) injection, solution. SPL setid 21fbd12e-4a12-4ad1-ad01-964cd5ec9996, NDC 24208-002-02.

• U.S. National Library of Medicine DailyMed. AMPHADASE (hyaluronidase) injection. Revised February 2024, highlights revised September 2024. Amphastar Pharmaceuticals, Inc., BLA 021665.

• U.S. Food and Drug Administration. AMPHADASE (hyaluronidase injection) prescribing information. BLA 021665/S-007, action date August 28, 2024. Amphastar Pharmaceuticals, Inc.

• U.S. Food and Drug Administration. AMPHADASE (hyaluronidase injection) prescribing information (2012). NDA 21-665/S-005, approved 2012. Documents historical optional intradermal skin-test protocol.

• U.S. Food and Drug Administration. VITRASE (hyaluronidase injection) prescribing information (2018). NDA 021640/S-025, approved 2018. Documents historical 0.02 mL (4 Units) ovine skin-test protocol.

• U.S. Food and Drug Administration. HYLENEX recombinant prescribing information (2016). NDA 21859/S-023, approved 2016. Documents historical recombinant skin-test wording.

• U.S. Food and Drug Administration. Drugs@FDA: Hylenex Recombinant, BLA 021859. Original approval December 2, 2005. Halozyme Therapeutics, Inc.

• U.S. Food and Drug Administration. Drugs@FDA: Vitrase, BLA 021640. Original approval May 5, 2004. Bausch & Lomb Incorporated.

• U.S. Food and Drug Administration. Drugs@FDA: Amphadase, BLA 021665. Original approval October 26, 2004. Amphastar Pharmaceuticals, Inc.

• U.S. Food and Drug Administration. Drugs@FDA: Hydase, BLA 021716. Original approval October 25, 2005; marketing status Discontinued. Akorn Inc.

• U.S. Food and Drug Administration. Purple Book: Database of Licensed Biological Products — Hylenex Recombinant. BLA 021859, 351(a) Biologics License, Halozyme Therapeutics, Inc.

• U.S. Government Publishing Office. 21 CFR 201.57: Specific Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products. Electronic Code of Federal Regulations.

• U.S. Food and Drug Administration. Understanding Unapproved Use of Approved Drugs 'Off Label'. FDA Center for Drug Evaluation and Research Patient Guidance.

• U.S. Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the FD&C Act. Guidance for Industry, January 2018.

• Halozyme Therapeutics. Hylenex Recombinant (hyaluronidase injection) Healthcare Professional Site. Product indication, recombinant manufacturing specifications, and safety summary.