FDA.reportPublic FDA data

NDC 65293-015-01 - Orbactiv

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
65293-015
Requested NDC
65293-015-01
Package NDCs from labels
65293-015-01, 65293-015-03
Manufacturer
The Medicines Company | AndersonBrecon Inc. | AbbVie Inc. | Patheon Italia S.p.A. | Carton Service, Incorporated
Effective date
2020-02-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OrbactivThe Medicines Company | AndersonBrecon Inc. | AbbVie Inc. | Patheon Italia S.p.A. | Carton Service, Incorporated2020-02-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65293-015-032020-02-11C16284748780-19d75b9d0-8e03-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ORBACTIV safely and effectively. See full prescribing information for ORBACTIV. ORBACTIV ® (oritavancin) for injection, for intravenous use Initial U.S. Approval: 2014
65293-015-032020-01-31C16284748780-19d75b9d0-8e03-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ORBACTIV safely and effectively. See full prescribing information for ORBACTIV. ORBACTIV ® (oritavancin) for injection, for intravenous use Initial U.S. Approval: 2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65293-015-01EA - Each65293-0155ab086a2-37f6-4c93-900d-074b4c2b2b8112014-10-03
65293-015-03EA - Each65293-015fbc9c6e5-6131-4d1f-9899-57f1991b86f712014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORITAVANCINACTIVE INGREDIENTPUG62FRZ2EORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]2
ORITAVANCINACTIVE MOIETYPUG62FRZ2EORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]2

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 9 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElimitoneBELLIS PERENNIS, ECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ARNICA MONTANA, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMEnergique, Inc.bc6352e0-6851-4971-948b-b18da7c1c8b62024-10-24WarningsExact identifier
unii: E4GA8884NN
Endopan HPACETICUM ACIDUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, URANIUM NITRICUMEnergique, Inc.0d475595-7afe-423f-9da8-720f1513f9562024-10-24WarningsExact identifier
unii: E4GA8884NN
Pericardium Triple Warmer Meridian OpenerARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, GLONOINUM, IODIUM, KALI IODATUM, LACHESIS MUTUS, LITHIUM CARBONICUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA, SPONGIA TOSTA, TABACUM, THYROIDINUM (SUIS)Deseret Biologicals, Inc.060ecfed-5d31-49ca-82d8-9b05355da59d2024-10-22WarningsExact identifier
unii: E4GA8884NN
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: E4GA8884NN
ThymoplexCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), CONDURANGO, GINKGO BILOBA, PINUS SYLVESTRIS, PROPOLIS, SPLEEN (SUIS), TABEBUIA IMPETIGINOSA, THYMUS (BOVINE), BEE POLLEN, HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, LACHESIS MUTUSBioActive Nutritional, Inc.1f4a9fda-c53e-4c0c-b624-aa48436c0aea2024-10-18WarningsExact identifier
unii: E4GA8884NN
SILICEA COMPLEX IIECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI CHLORICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUM, SILICONE (DIMETHICONE).BioActive Nutritional, Inc.df277f21-9e60-4c64-928a-b1d9251032822024-10-18WarningsExact identifier
unii: E4GA8884NN
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: E4GA8884NN
OrchiforceAVENA SATIVA, DAMIANA, AGNUS CASTUS, CALADIUM SEGUINUM, CONIUM MACULATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUMBioActive Nutritional, Inc.b002b03c-a772-403e-b0e8-3f75ad97208c2024-10-17WarningsExact identifier
unii: E4GA8884NN
ENERGIZERPHOSPHORICUM ACIDUM, COCCULUS INDICUS, HELONIAS DIOICA, IGNATIA AMARA, SEPIA, ZINCUM METALLICUMBioActive Nutritional, Inc.e3b8d4b2-1d6c-4fdc-9303-a1384c0d25de2024-10-17WarningsExact identifier
unii: E4GA8884NN
Bone Support HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPATORIUM PERFOLIATUM, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, STRONTIUM CARBONICUM, SYMPHYTUM OFFICINALEEnergique, Inc.da6937b9-da23-4e78-96af-2ca40f973a022024-09-30WarningsExact identifier
unii: E4GA8884NN
FNGBERBERIS VULGARIS, COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, TABEBUIA IMPETIGINOSA, THYMUS (SUIS), FORMALINUM, CARBOLICUM ACIDUM, FERRUM METALLICUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRASTENSIS), SELENIUM METALLICUM, ZINCUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, METHYLCOBALAMIN, SARCOLACTICUM ACIDUM, MUCOR RACEMOSUS, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER,Deseret Biologicals, Inc.fd32287e-af1a-45d3-b82a-5cc004db6bc92024-09-27WarningsExact identifier
unii: E4GA8884NN
Glucoseforce HPCOLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, URANIUM NITRICUMBioActive Nutritional, Inc.9ee10384-3f4b-496b-a543-a4de5baccd052024-09-11WarningsExact identifier
unii: E4GA8884NN
RadiationCAPSICUM ANNUUM, CETRARIA ISLANDICA, FUCUS VESICULOSUS, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), CADMIUM IODATUM, HYDRANGEA ARBORESCENS, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STRONTIUM CARBONICUM, URANIUM NITRICUM, X-RAYBioActive Nutritional1c49738c-6750-47de-a623-96f53eab7bad2024-09-11WarningsExact identifier
unii: E4GA8884NN
V HPARSENICUM ALBUM, BELLADONNA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOXEnergique, Inc.5a46f246-73cb-45d0-8a66-4884879323ce2024-08-13WarningsExact identifier
unii: E4GA8884NN
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHUR IODATUMBioActive Nutritional, Inc.7920e8f6-be48-4402-9085-9673779db5a22024-07-31WarningsExact identifier
unii: E4GA8884NN
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, ARSENICUM IODATUM, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.09d87efd-9ae3-45ea-8bb6-3e507ae31cfb2024-07-29WarningsExact identifier
unii: E4GA8884NN
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: E4GA8884NN
Adrenal SupportARALIA QUINQUEFOLIA, HUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.50f48780-b222-471a-afa5-1504960d48942024-07-29WarningsExact identifier
unii: E4GA8884NN
Adrenal HomeopathicCAPSICUM ANNUUM, GLANDULA SUPRARENALIS SUIS, FERRUM METALLICUM, AMMONIUM MURIATICUM, KALI CARBONICUM, NUX VOMICA, PHOSPHORICUM ACIDUMEnergique, Inc.5fe2ae3c-75ca-4907-ac4c-905d34cc5b802024-07-16WarningsExact identifier
unii: E4GA8884NN
AdditivestatTRIFOLIUM PRATENSE, PETROLEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, NITRICUM ACIDUMEnergique, Inc.8a9490c2-1fdb-43b4-aeae-6e783b333f032024-07-16WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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