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 30 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nat MurNATRUM MURIATICUMEnergique, Inc.39c4cb25-e70f-4d5a-b7b6-1b62527aa4f32024-10-29WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC68cc9c41-ed24-4f76-8efb-2936ae3ddd8d2024-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: LX22YL083G
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, FAGOPYRUM ESCULENTUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.d008a091-b7c6-41f1-a1cf-f8224ebe55e52024-10-29WarningsExact identifier
unii: 451W47IQ8X
Multi-Cell SaltKALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEAEnergique, Inc.dad00225-b3ac-4e36-a856-19b0faf42c422024-10-29WarningsExact identifier
unii: 451W47IQ8X
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: 451W47IQ8X
DERMATOME HPLYCOPODICUM CLAVATUM, MEZEREUM, NATRUM MURIATICUM,Energique, Inc.54a096ac-7ebe-4565-b1b0-0473de16e70c2024-10-24WarningsExact identifier
unii: 451W47IQ8X
Complexion HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMEnergique, Inc.ad12d51e-04cb-4833-b802-0038796966ff2024-10-24WarningsExact identifier
unii: 451W47IQ8X
CV HPADONIS VERNALIS, LACHESIS MUTUS, LYCOPUS VIRGINICUS, VALERIANA OFFICINALIS, AURUM METALLICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS),ENERGIQUE, INC.c06763c5-8bde-4251-bd41-67becf8ce8c42024-10-24WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.2af0dc7b-5f8b-44fa-9589-bc95043428e92024-10-24WarningsExact identifier
unii: 451W47IQ8X
OratoxFUCUS VESICULOSUS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA MURIATICA, IODIUM, NATRUM FLUORATUM, NATRUM MURIATICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.b78d8991-ffbe-4b11-b9b9-8fe432bed8aa2024-10-23WarningsExact identifier
unii: 451W47IQ8X
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.a631a250-d6d8-479c-a53e-347ac908c5ff2024-10-22WarningsExact identifier
unii: 451W47IQ8X
MetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: 451W47IQ8X
RhustoxoforceAPIS MELLIFICA, CANTHARIS, GRAPHITES, NATRUM MURIATICUM, RHUS GLABRA, RHUS TOXICODENDRON, RHUS VENENATA, URTICA DIOICABioActive Nutritional, Inc.5a3627f1-a850-42f3-8c7a-b2067bd035382024-10-18WarningsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBecton Dickinson and Companybb2ad9cd-5d9a-4337-be61-0842d738c79e2024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC8fce1477-991f-4b43-bf05-a80bad8972622024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc44b0fdb-33df-4747-b443-5fb4deb456cb2024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCe5e325d1-0d58-40c9-9645-3ae402ff9d922024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: LX22YL083G
Vamousse Lice DefenseEUCALYPTUS GLOBULUS, NATRUM MURIATICUMAlliance Pharma Inc.c87ce5d3-c200-421e-88be-bc8060a5993a2024-10-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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