HYLENEX Recombinant
- Product NDC
- 18657-117
- 11-digit product format
- 186570117
- Labeler code
- 18657
- Product ID
- 18657-117_37c02d08-e964-4065-ba96-69fe8eed5c2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hyaluronidase
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Antares Pharma, Inc.
- Application
- BLA021859
- Marketing category
- BLA
- Marketing start
- 2005-12-02
- Substance
- HYALURONIDASE (HUMAN RECOMBINANT)
- Active strength
- 150 [USP'U]/mL
- Pharmacologic classes
- Endoglycosidase [EPC], Glycoside Hydrolases [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYLENEX Recombinant
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYALURONIDASE (HUMAN RECOMBINANT) | 150 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 743QUY4VD8 |
| Rxcui | 630936, 630939 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 18657-117-04 | 2023-07-19 | C162847 | 48780-1 | f386c649-dc27-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase) injection for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use or for subcutaneous use Initial U.S. Approval: 2005 |
| 18657-117-04 | 2023-01-30 | C162847 | 48780-1 | f386c649-dc27-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase) injection for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use or for subcutaneous use Initial U.S. Approval: 2005 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 18657-117-01 | HYLENEX Recombinant | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 11 |
| 18657-117-02 | HYLENEX Recombinant | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 11 |
| 18657-117-04 | HYLENEX Recombinant | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Hyaluronidase (Human Recombinant) | ACTIVE INGREDIENT | 743QUY4VD8 | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
| Hyaluronidase (Human Recombinant) | ACTIVE MOIETY | 743QUY4VD8 | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
| albumin human | INACTIVE INGREDIENT | ZIF514RVZR | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
| Methionine | INACTIVE INGREDIENT | AE28F7PNPL | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 18657-117 | HYLENEX RECOMBINANT (HYALURONIDASE) INJECTION, SOLUTION [ANTARES PHARMA, INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20250423_3023cc56-ed4b-4e87-b3a1-81b20943f658.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 630936 | hyaluronidase, human recombinant 150 UNT in 1 ML Injection | PSN | 3023cc56-ed4b-4e87-b3a1-81b20943f658 | 11 |
| 630939 | Hylenex 150 UNT in 1 ML Injection | PSN | 3023cc56-ed4b-4e87-b3a1-81b20943f658 | 11 |
| 630939 | 1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex] | SBD | 3023cc56-ed4b-4e87-b3a1-81b20943f658 | 11 |
| 630936 | 1 ML hyaluronidase, human recombinant 150 UNT/ML Injection | SCD | 3023cc56-ed4b-4e87-b3a1-81b20943f658 | 11 |
| 630936 | hyaluronidase, human recombinant 150 UNT per 1 ML Injection | SY | 3023cc56-ed4b-4e87-b3a1-81b20943f658 | 11 |
| 630939 | Hylenex 150 UNT per 1 ML Injection | SY | 3023cc56-ed4b-4e87-b3a1-81b20943f658 | 11 |
| 630936 | hyaluronidase, human recombinant 150 UNT in 1 ML Injection | PSN | c3f1db01-58bf-2226-e053-2a95a90a8b33 | 1 |
| 630939 | Hylenex 150 UNT in 1 ML Injection | PSN | c3f1db01-58bf-2226-e053-2a95a90a8b33 | 1 |
| 630939 | 1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex] | SBD | c3f1db01-58bf-2226-e053-2a95a90a8b33 | 1 |
| 630936 | 1 ML hyaluronidase, human recombinant 150 UNT/ML Injection | SCD | c3f1db01-58bf-2226-e053-2a95a90a8b33 | 1 |
| 630936 | hyaluronidase, human recombinant 150 UNT per 1 ML Injection | SY | c3f1db01-58bf-2226-e053-2a95a90a8b33 | 1 |
| 630939 | Hylenex 150 UNT per 1 ML Injection | SY | c3f1db01-58bf-2226-e053-2a95a90a8b33 | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 18657-117-01 | 18657011701 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 18657-117-02 | 18657011702 | 1 in 1 BOX | | | | | | Historical |
| 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) | 4 box | 2005-12-02 | 0000-00-00 | No | No | Current |