FDA.reportPublic FDA data

NDC 0338-9581-01 - doxorubicin hydrochloride, Liposomal

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
0338-9581
Requested NDC
0338-9581-01
Package NDCs from labels
0338-9581-01, 0338-9581-02
Manufacturer
Baxter Healthcare Corporation
Effective date
2023-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
doxorubicin hydrochloride, Liposomal - Baxter Healthcare CorporationBaxter Healthcare Corporation2023-12-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9581-01doxorubicin hydrochloride, Liposomal10 mL in 1 VIAL, SINGLE-USEINJECTION, SUSPENSION, LIPOSOMAL103
0338-9581-02doxorubicin hydrochloride, Liposomal1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9581DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [BAXTER HEALTHCARE CORPORATION]2Current NDC, 2 package rows20241101_b24afa8c-636b-4ace-99d5-51f445ad3123.zip

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 1 of 9 · 170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
unii: 97C5T2UQ7J
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 4QD397987E
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEBluePoint Laboratories55889588-c5f1-d9bc-e063-6294a90a57912026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1790115
unii: 82F2G7BL4E
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesf6508535-e7a7-4e50-8d0c-43deda8d0d082026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1790115
unii: 82F2G7BL4E
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc1fd148fb-0fbc-4b6f-b790-23546fb46a712026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc00634b2b-4e48-4178-8877-28582af894ad2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDENorthStar RxLLCddf55319-bf62-4ec7-8be2-ef97188837c42026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1790115
unii: 82F2G7BL4E
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.fbc48fa5-0bfb-4957-b13c-a56bb7a13b562026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1790115
unii: 82F2G7BL4E
CirculatoneFAGOPYRUM ESCULENTUM, MAGNESIA MURIATICA, CITRUS BIOFLAVONOIDS, HEART (SUIS), THYROIDINUM (SUIS), ARSENICUM IODATUM, AURUM MURIATICUM, BARYTA MURIATICA, CALCAREA IODATA, CHOLESTERINUM, CONIUM MACULATUM, KALI IODATUM, PLUMBUM METALLICUM, ARNICA MONTANA, PHOSPHORUSBioActive Nutritional, Inc.465fb3c6-88e6-4099-a26a-33991ec5a1062026-03-31WarningsExact identifier
unii: 97C5T2UQ7J
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEBluePoint Laboratoriesada390ce-50ea-4de5-be58-5b03caf33c232026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1790115
unii: 82F2G7BL4E
doxorubicin hydrochlorideDOXORUBICIN HYDROCHLORIDEDr. Reddy's Laboratories Inc.0885dddf-727e-4692-92dd-a26c69cc278d2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1790115
unii: 82F2G7BL4E

Reported adverse events (FAERS/openFDA)#

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