FDA.reportPublic FDA data

NDC 59353-010-01 - RETACRIT

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
59353-010
Requested NDC
59353-010-01
Package NDCs from labels
59353-010-01, 59353-010-10
Manufacturer
Vifor (International) Inc. | Hospira, Inc.
Effective date
2025-06-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RETACRIT - Vifor (International) Inc. | Hospira, Inc.Vifor (International) Inc. | Hospira, Inc.2025-06-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59353-010-01RETACRIT1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION114
59353-010-10RETACRIT10 in 1 CARTONINJECTION, SOLUTION1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59353-010RETACRIT (EPOETIN ALFA-EPBX) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]13Current NDC, Legacy NDC, 2 package rows20240627_e6e4dd0c-25ca-40b2-ba6b-6138a68621fe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59353-010-01ML - Milliliter59353-010393ba739-580a-4a86-97bd-556482a9e90812018-07-03
59353-010-10ML - Milliliter59353-01035389455-ba5b-4c8b-997e-0a224149294912018-07-03

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 40 of 59 · 1,170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineffect eye dropsALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltde2259f58-3043-4af3-918d-d4403757aa1f2024-04-26WarningsExact identifier
unii: 451W47IQ8X
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC7a723a23-3bc1-4f69-b82f-d06a35dc68d62024-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc1e52670-c85e-4f19-a2e9-bf9abd7c37272024-04-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: C151H8M554
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
DermaparEPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUMEnergique, Inc.f79fe29b-341e-4bee-9665-1805a7157d1a2024-04-22WarningsExact identifier
unii: 451W47IQ8X
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: QTT17582CB
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHikma Pharmaceuticals USA Inc.e5ee8caa-b6ca-45ba-98fb-8305e62821412024-04-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hers PlusCALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALISDeseret Biologicals,Inc.e4636b80-f6c8-459c-8d0e-ff7801358b102024-04-09WarningsExact identifier
unii: 451W47IQ8X
SINU HCPLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUMDeseret Biologicals, Inc.8b63e066-dd1b-4aee-a17b-4edc6b71a1cc2024-04-02WarningsExact identifier
unii: 451W47IQ8X
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Oral HealthANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,Deseret Biologicals, Inc.6f66ff40-6e0e-4a35-963c-965c65df76eb2024-04-01WarningsExact identifier
unii: QTT17582CB
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy14931004-1efb-e331-e063-6294a90ad66e2024-03-26WarningsExact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron14945760-30b5-27d3-e063-6394a90a8a322024-03-26Exact identifier
unii: 451W47IQ8X
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: 451W47IQ8X
Calcium ChlorideCALCIUM CHLORIDEAmerican Regent, Inc.c5ef90b3-6ef0-410c-97d7-66a130b907412024-03-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.59ccc717-c374-41c0-be58-9647df8811602024-03-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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