FDA.reportPublic FDA data

NDC 71274-350-01 - Ruconest

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
71274-350
Requested NDC
71274-350-01
Package NDCs from labels
71274-350-01, 71274-350-02
Manufacturer
Tjoapack Netherlands BV
Effective date
2022-10-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ruconest - Tjoapack Netherlands BVTjoapack Netherlands BV2022-10-24HUMAN PRESCRIPTION DRUG LABEL
Ruconest - Pharming Healthcare Inc.Pharming Healthcare Inc.2020-04-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71274-350-01Ruconest1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION13
71274-350-02Ruconest1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71274-350RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [PHARMING HEALTHCARE INC.]3Current NDC, Legacy NDC, 2 package rows20200605_66d3fecb-32a4-7781-e053-2a91aa0a83ca.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71274-350-01EA - Each71274-35075bf7928-924b-4edb-ba6c-81060b02cde012018-08-13
71274-350-02EA - Each71274-350617c2e53-4a5d-47ee-b036-8570cd79371012018-08-13

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 3 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEBelleview Biosciences LLC3245e0e5-5e7f-c3f7-e063-6394a90ac2582025-07-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 1Q73Q2JULR
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
PhexxLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.14b01a15-9b47-4be3-bb2e-a2010eab429e2025-05-02Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 1Q73Q2JULR
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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