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 34 of 45 · 899 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALISEnergique, Inc.3cdddbe5-e3d2-4629-a045-868e18183f1d2023-12-19WarningsExact identifier
unii: 451W47IQ8X
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
unii: 451W47IQ8X
terrasil Eczema and Psoriasis Severe OutbreakGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions4d7128fb-57f1-4d0d-a83a-daef40928ecd2023-11-30WarningsExact identifier
unii: 451W47IQ8X
terragen HG Formula Maximum StrengthGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse632c831-e25d-4d04-ba72-2327d25713b12023-11-30WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 451W47IQ8X
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: 451W47IQ8X
MetaloginALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, L-METHIONINE, THYROIDINUM (SUIS), SELENIUM DIOXIDE, LYCOPODIUM CLAVATUM, NUX VOMICA, LANTHANUM OXIDE, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUMBioActive Nutritional, Inc.2bd32205-a9d5-418a-90fd-0c3be29c04e92023-11-17WarningsExact identifier
unii: AE28F7PNPL
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643994f-4e13-4572-e053-2991aa0a5b782023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron6907bbfe-caa5-2ce4-e053-2991aa0ade8d2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643c518-13b2-658a-e053-2a91aa0ac5ed2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643e30e-1f47-09f1-e053-2991aa0ac2de2023-11-14Exact identifier
unii: QTT17582CB
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466121-7217-d053-e053-2a91aa0a8f8a2023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron864669c9-5bdc-232f-e053-2a91aa0a1fc62023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: QTT17582CB
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
Ahh SleepCOFFEA CRUDAMicro Balance Health Products08ea860f-0183-8ce8-e063-6394a90a582b2023-10-30WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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