Home NDC 18657-117 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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 743QUY4VD8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 630936 Internal RxNorm lookup 630939 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021859 Hylenex recombinant hyaluronidase human 351(a) Rx 2026-08-01
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