FDA.reportPublic FDA data

NDC 57902-249-01 - ERWINAZE

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
57902-249
Requested NDC
57902-249-01
Package NDCs from labels
57902-249-01, 57902-249-05
Manufacturer
Jazz Pharmaceuticals, Inc.
Effective date
2020-06-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ERWINAZE - Jazz Pharmaceuticals, Inc.Jazz Pharmaceuticals, Inc.2020-06-28HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-10-13These highlights do not include all the information needed to use ERWINAZE ® safely and effectively. See full prescribing information for ERWINAZE. ERWINAZE (asparaginase Erwinia chrysanthemi ) for injection, for intramuscular or intravenous use Initial U.S. Approval: 2011
2020-09-27These highlights do not include all the information needed to use ERWINAZE ® safely and effectively. See full prescribing information for ERWINAZE. ERWINAZE (asparaginase Erwinia chrysanthemi ) for injection, for intramuscular or intravenous use Initial U.S. Approval: 2011
2020-09-25These highlights do not include all the information needed to use ERWINAZE ® safely and effectively. See full prescribing information for ERWINAZE. ERWINAZE (asparaginase Erwinia chrysanthemi ) for injection, for intramuscular or intravenous use Initial U.S. Approval: 2011
2020-07-22These highlights do not include all the information needed to use ERWINAZE ® safely and effectively. See full prescribing information for ERWINAZE. ERWINAZE (asparaginase Erwinia chrysanthemi ) for injection, for intramuscular or intravenous use Initial U.S. Approval: 2011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57902-249-01EA - Each57902-249ab7f6dce-573a-4659-81f2-fd7fd1ef9ac012012-07-24
57902-249-05EA - Each57902-249693cd689-6618-4c9f-a91c-5d5deb61582d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPARAGINASE ERWINIA CHRYSANTHEMIACTIVE INGREDIENTD733ET3F9OERWINAZE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]13
ASPARAGINASEACTIVE MOIETYG4FQ3CKY5RERWINAZE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]13
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GERWINAZE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XERWINAZE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]13

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 31 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Energy CatalystVISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS, POTASSIUM ASPARTATE, SODIUM MOLYBDATE, ADENOSINUM, CYCLOPHOSPHORICUM, CERIUM OXALICUM, NICKEL ACETATE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, ALUMINA,Deseret Biologicals, Inc.99529dd4-f8ab-4348-8b65-dc8c89e1ad542024-10-04WarningsExact identifier
unii: 451W47IQ8X
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: LX22YL083G
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, LAPIS ALBUS, LEVOTHYROXINUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SELENIUM METALLICUM, SPONGIA TOSTA, THYROIDINUM (SUIS)Energique, Inc.2f04e425-7160-41a7-aa1e-934db54f17512024-09-30WarningsExact identifier
unii: 451W47IQ8X
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporatedcc3d5bc8-9d3c-4c65-9e43-707a2db4081a2024-09-25WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated93fafa27-5031-4d95-b4b8-5574b7204ae22024-09-25WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated454f337e-d897-46de-ab05-1c543a33061c2024-09-25WarningsExact identifier
unii: 451W47IQ8X
DefensePETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR (BOVINE), MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (OVINE), SACCHARINUMNutritional Specialties, Inc.ddd879cf-1a85-4b8d-bdb0-5cf495fea4e62024-09-24WarningsExact identifier
unii: 451W47IQ8X
HP AxisARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONEDeseret Biologicals, Inc.402f5b05-c71e-4dba-bc2b-049aee42952a2024-09-23WarningsExact identifier
unii: 451W47IQ8X
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC3c5f0f65-8a54-4a55-ad4e-0f0be97631d72024-09-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: LX22YL083G
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SPONGIA TOSTA, THYROIDINUM (SUIS)Energique, Inc.3a4f9647-a4d9-4bca-96d1-ec717f938d4a2024-09-11WarningsExact identifier
unii: 451W47IQ8X
DefensePETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR SUIS, MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (BOVINE) SACCHARINUMNutritional Specialties, Inc.b5516749-54dd-4287-b2db-78164810de7a2024-09-11WarningsExact identifier
unii: 451W47IQ8X
Itch FormulaCALENDULA OFFICINALIS, APIS MELLIFICA, NATRUM MURIATICUM, URTICA URENS, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, SULPHUR, COPAIVA OFFICINALIS, CANTHARIS, CROTON TIGLIUM, GRAPHITES, MEZEREUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, ANTIPYRINUMDeseret Biologicals, Inc.79c21a7b-ffb7-4b0d-a702-8aec0463be812024-09-11WarningsExact identifier
unii: 451W47IQ8X
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA (AMERICAN GINSENG), GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, EPHEDRA VULGARIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.9f8e7917-33df-4059-9ae9-e3d2fbb8e3192024-09-03WarningsExact identifier
unii: 451W47IQ8X
Gum TherapyACONITUM NAPELLUS, ARNICA MONTANA, BISMUTHUM SUBNITRICUM, BORAX, CALCAREA FLUORICA, CALENDULA OFFICINALIS, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, KALI PHOSPHORICUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NATRUM MURIATICUM, SEPIADeseret Biologicalsceb5203b-b4c8-4c7b-8e18-ccbff5034fc12024-08-29WarningsExact identifier
unii: 451W47IQ8X
Gum TherapyCALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, BORAX, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUSDeseret Biologicals5c741edc-f3ce-4e43-bb3e-fb73166214062024-08-28WarningsExact identifier
unii: 451W47IQ8X
Upper Respiratory SupportALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, SALVIA OFFICINALIS, DULCAMARA, EUPHRASIA OFFICINALIS, HYDRASTIS CANADENSIS, NATRUM MURIATICUM, SABADILLA, VISCUM ALBUM, MUCOSA NASALIS SUIS, ACONITUM NAPELLUS, AMMONIUM CARBONICUM, ARSENICUM IODATUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (PRATENSIS), RHUS TOXDeseret Biologicals, Inc.882a284f-aa25-40cf-8aff-fe4c38ff3f0a2024-08-23WarningsExact identifier
unii: 451W47IQ8X
DextroseDEXTROSE MONOHYDRATEFRESENIUS KABI USA, LLC576a22d8-5f2f-497e-80ad-1842ca74bb532024-08-22Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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