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 6 of 9 · 170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hormone CombinationACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO- DEHYDROEPIANDROSTERONE 3-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEDeseret Biologicals, Inc.22908e3d-492c-4b18-a070-076f99a813142024-03-11WarningsExact identifier
unii: 97C5T2UQ7J
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: C151H8M554
Cand PlusHYDRASTIS CANADENSIS, BERBERIS VULGARIS, BORAX, SACCHARUM OFFICINALE, CAFFEINUM, GALLICUM ACIDUM, INDOLUM, ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), ASAFOETIDA, ACETALDEHYDE, FOLLICULINUM, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), SEPIA, USTILAGO MAIDIS, TORULA CEREVISIAEDeseret Biologicals, Inc.1f8ab864-27c2-4457-8ad7-5d65f9983e2c2024-03-06WarningsExact identifier
unii: C151H8M554
Oral HealthBORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsExact identifier
unii: QTT17582CB
EPST PLUSCARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLADeseret Biologicals, Inc.c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc252024-02-27WarningsExact identifier
unii: QTT17582CB
Detox ICARDUUS MARIANUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, TARAXACUM OFFICINALE, AVENA SATIVA, CYNARA SCOLYMUS, METHYLCOBALAMIN, MENADIONE, ALPHA-LIPOICUM ACIDUM, CINCHONA OFFICINALIS, HEPAR SUIS, VERATRUM ALBUM, COLON (SUIS), DUODENUM (SUIS), GALLBLADDER (SUIS), INTESTINE (SUIS), LYMPH NODE (SUIS), PANCREAS SUIS, THYMUS (SUIS), ACETALDEHYDE, ALPHA-KETOGLUTARICUM ACIDUM, CHOLESTERINUM, FORMICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, MALIC ACID, NATRUM OXALACETICUM, SULPHUR, CALCAREA CARBONICA,Deseret Biologicals, Inc.759c7688-0104-41fe-be1e-4809c9be86862024-02-13WarningsExact identifier
unii: 97C5T2UQ7J
Hormone HarmonyACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO- DEHYDROEPIANDROSTERONE 3-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEPro Weight Loss Inc.123f5269-45eb-4dcd-be66-76c6665b8d132024-01-22WarningsExact identifier
unii: 97C5T2UQ7J
D1 Organ SupportCARDUUS MARIANUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, TARAXACUM OFFICINALE, AVENA SATIVA, CYNARA SCOLYMUS, METHYLCOBALAMIN, MENADIONE, ALPHA-LIPOICUM ACIDUM, CINCHONA OFFICINALIS, HEPAR SUIS, VERATRUM ALBUM, COLON (SUIS), DUODENUM (SUIS), GALLBLADDER (SUIS), INTESTINE (SUIS), LYMPH NODE (SUIS), PANCREAS SUIS, THYMUS (SUIS), THYMUS (SUIS), ALPHA-KETOGLUTARICUM ACIDUM, CHOLESTERINUM, FORMICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, MALICUM ACIDUM, NATRUM OXALACETICUM, SULPHUR, CALCAREA CARBONICA,Dr. Donna Restivo DCe295c5a0-82ca-4fe9-a2e2-9407d81b780e2024-01-18WarningsExact identifier
unii: 97C5T2UQ7J
Doxorubicin HydrochlorideDOXORUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.971de64b-ff09-4370-afd9-6eb1093ad27d2024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82F2G7BL4E
A04 DEEP ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUMApex Energetics Inc.b9bbbddf-b822-4780-e053-2a95a90afbba2024-01-08WarningsExact identifier
unii: C151H8M554
A13 DTX-LIVERBOS TAURUS GALLBLADDER, BRYONIA, CHELIDONIUM MAJUS, CHOLESTERINUM, HEPAR SULPHURIS CALCAREUM , JUNIPERUS COMMUNIS STEM, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORUS, RHAMNUS PURSHIANA, ROSMARINUS OFFICINALIS, SECALE CEREALE WHOLEApex Energetics Inc.bed751f5-a8da-cac7-e053-2a95a90a22182024-01-08WarningsExact identifier
unii: 97C5T2UQ7J
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
C08 CALCIUM METABOLISMABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN DApex Energetics Inc.bd09a34f-1615-09f0-e053-2995a90ac2ef2024-01-08WarningsExact identifier
unii: 97C5T2UQ7J
doxorubicin hydrochloride, LiposomalDOXORUBICIN HYDROCHLORIDEBaxter Healthcare Corporationb24afa8c-636b-4ace-99d5-51f445ad31232023-12-19Exact identifier
ndc (package): 0338-9581-01
ndc (package): 0338-9581-02
ndc (product): 0338-9581
ndc11 (package): 00338958101
rxcui: 1790115
spl id: a4227051-225f-49e2-9e5c-653ea0f99739
spl set id: b24afa8c-636b-4ace-99d5-51f445ad3123
unii: 82F2G7BL4E
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643994f-4e13-4572-e053-2991aa0a5b782023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron6907bbfe-caa5-2ce4-e053-2991aa0ade8d2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643c518-13b2-658a-e053-2a91aa0ac5ed2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643e30e-1f47-09f1-e053-2991aa0ac2de2023-11-14Exact identifier
unii: QTT17582CB
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Exact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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