FDA.reportPublic FDA data

NDC 18657-117-01 - HYLENEX Recombinant

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
18657-117
Requested NDC
18657-117-01
Package NDCs from labels
18657-117-01, 18657-117-02, 18657-117-04
Manufacturer
Antares Pharma, Inc. | Patheon Manufacturing Services LLC
Effective date
2024-11-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYLENEX Recombinant - Antares Pharma, Inc. | Patheon Manufacturing Services LLCAntares Pharma, Inc. | Patheon Manufacturing Services LLC2024-11-11HUMAN PRESCRIPTION DRUG LABEL
HYLENEX Recombinant - A-S Medication SolutionsA-S Medication Solutions2023-02-04HUMAN PRESCRIPTION DRUG LABEL
HYALURONIDASE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2021-06-04HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
18657-117-042023-07-19C16284748780-1f386c649-dc27-0266-e053-dadaa90a7c1aThese 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
18657-117-042023-01-30C16284748780-1f386c649-dc27-0266-e053-dadaa90a7c1aThese 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 NDCProductDescriptionFormQuantityStrengthSPL version
18657-117-01HYLENEX Recombinant1 mL in 1 VIALINJECTION, SOLUTION111
18657-117-02HYLENEX Recombinant1 in 1 BOXINJECTION, SOLUTION111
18657-117-04HYLENEX Recombinant4 in 1 CARTONINJECTION, SOLUTION411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
18657-117HYLENEX RECOMBINANT (HYALURONIDASE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]11Current NDC, Legacy NDC, 3 package rows20250423_3023cc56-ed4b-4e87-b3a1-81b20943f658.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
18657-117-01ML - Milliliter18657-117bd26c69f-8af6-4bcf-af56-cbc1d1150d5812015-07-20
18657-117-02ML - Milliliter18657-117b46fac61-7f2d-436c-826c-951c55f634c412015-07-20
18657-117-04ML - Milliliter18657-117507786e4-3df9-4a8a-a3f7-2f1cdd5d367712015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hyaluronidase (Human Recombinant)ACTIVE INGREDIENT743QUY4VD8HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2
Hyaluronidase (Human Recombinant)ACTIVE MOIETY743QUY4VD8HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2
albumin humanINACTIVE INGREDIENTZIF514RVZRHYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBHYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2
MethionineINACTIVE INGREDIENTAE28F7PNPLHYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HHYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XHYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IHYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [HALOZYME, INC.]2

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 11 of 48 · 951 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opsin II 6015OPSIN IIProfessional Complementary Health Formulas848d620e-ddd5-4787-a4bd-844be76154322026-01-08WarningsExact identifier
unii: 451W47IQ8X
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: 451W47IQ8X
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Proteinuria Drops 2053PROTEINURIA DROPSProfessional Complementary Health Formulas1bf80282-8283-4835-acd4-fbdb47788c672026-01-08WarningsExact identifier
unii: ZIF514RVZR
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Shingles Nosode 4028SHINGLES NOSODEProfessional Complementary Health Formulase71d917a-af9f-41e9-a3de-cb588db7e0222026-01-08WarningsExact identifier
unii: 451W47IQ8X
HealthMart Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC689228de-1f3e-4205-853d-6004d62488572026-01-08WarningsExact identifier
unii: GR686LBA74
Immune System Stimulator Drops 2033IMMUNE SYSTEM STIMULATOR DROPSProfessional Complementary Health Formulasf4595c63-1c9c-48a6-a13a-3659991f455b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Gallbladder 7007RET GALLBLADDERProfessional Complementary Health Formulas82bc7b50-aea3-4993-b171-919940fef2972026-01-08WarningsExact identifier
unii: 451W47IQ8X
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: 451W47IQ8X
L-Methionine 7417L-METHIONINEProfessional Complementary Health Formulas733cd224-813e-4e69-8aff-c8ec4ced325a2026-01-08WarningsExact identifier
unii: AE28F7PNPL
RET Pituitary/Sex 7012RET PITUITARY/SEXProfessional Complementary Health Formulas5081185c-1598-4bf5-b47b-b15135c453fb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
Melancholy Drops Extrovert 2015MELANCHOLY DROPS EXTROVERTProfessional Complementary Health Formulas2c9187ce-a52e-445e-a36e-fe374f5ad2e22026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Stim Liquescence 3028SPLEEN STIM LIQUESCENCEProfessional Complementary Health Formulas463b62a5-4d4f-445f-ba24-859195730cab2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 8009NATRUM MURIATICUMProfessional Complementary Health Formulasb4a48b58-28c0-4368-83e8-40ce52ae5f2b2026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.