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 11 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
F07 LVJYALOE VERA, BIG SAGEBRUSH, BORAGE, CALIFORNIA WILDROSE, CALOCHORTUS GUNNISONII, CAUSTICUM, CHICORY, COFFEA CRUDA, CROCUS SATIVUS, DICENTRA FORMOSA, DIPLACUS AURANTIACUS, ENGLISH HAWTHRON, ENGLISH HOLLY, EUROPEAN ASPEN, FLOWERING QUINCE, FORKING LARKSPUR, MIMULUS GUTTATUS, NASTURTIUM, PHOSPHORICUM ACIDUM, STROPHANTHUS HISPIDUS, WILD MUSTARD, YELLOW STAR THISTLE, YERBA SANTA, ZINNIA ELEGANSApex Energetics Inc.bc928980-0f46-7e49-e053-2995a90a22532024-01-08WarningsExact identifier
unii: E4GA8884NN
F15 MND-MMRYAGNUS CASTUS, ALLEGHENY MONKEYFLOWER, ANACARDIUM ORIENTALE, ARNICA MONTANA, ARNICA MONTANA FLOWER, BANANA, COMFREY, CALOCHORTUS GUNNISONII, CITRUS PARADISI, CORNUS NUTTALLII, EHRENDORFERIA CHRYSANTHA, MELILOTUS OFFICINALIS, MYOSOTIS SYLVATICA, IGNATIA AMARA, KALI BROMATUM, LAC CANINUM, ORNITHOGALUM UMBELLATUM, PEPPERMINT, PHOSPHORICUM ACIDUM, PHOSPHORUS, PINUS SYLVESTRIS, RANUNCULUS BULBOSUS, RUDBECKIA HIRTA, SAGUARO, TOXICODENDRON DIVERSILOBUM, YARROW, YERBA SANTA, ZINNIA ELEGANSApex Energetics Inc.bf3bbec4-f9e0-5a2d-e053-2a95a90ab1532024-01-08WarningsExact identifier
unii: E4GA8884NN
G16 ELECTRO-METADENOSINE TRIPHOSPHATE, ANTIMONY POTASSIUM TARTRATE, CINCHONA OFFICINALIS BARK, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, SULFURApex Energetics Inc.ba729a30-8450-4e5c-e053-2995a90af7fc2024-01-08WarningsExact identifier
unii: E4GA8884NN
F20 VTLTYACER NIGRUM, AESCULUS HIPPOCASTANUM, AGNUS CASTUS, ALFALFA, ALOE VERA, AMERICAN GINSENG, ARNICA MONTANA, BORAGE FLOWER, CAYENNE, CHININUM ARSENICOSUM, CORNUS NUTTALLII, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN HORSE CHESTNUT, EUROPEAN OLIVE, FUCHSIA, IRIS MISSOURIENSIS, LILAC, NASTURTIUM, NELUMBO NUCIFERA, NUX VOMICA, PEACH FLOWER, PHOSPHORICUM ACIDUM, PRUNELLA VULGARIS, RUDBECKIA HIRTA, SCARLET PIMPERNEL, SPICEBUSH, VERBENA OFFICINALIS, ZINNIA ELEGANSApex Energetics Inc.bf8ca9c7-d405-b231-e053-2a95a90a59802024-01-08WarningsExact identifier
unii: E4GA8884NN
ENERGY FormulaADENOSINE TRIPHOSPHATE, ANTIMONY POTASSIUM TARTRATE, CINCHONA OFFICINALIS BARK, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, SULFURApex Energetics Inc.d8c773f7-504a-bb56-e053-2a95a90aefcc2024-01-08WarningsExact identifier
unii: E4GA8884NN
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: E4GA8884NN
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron869341a5-be11-4351-e053-2a91aa0a5eec2023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoironae0094e0-7bf0-11e6-8451-424c583030312023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron8693b9fd-b02f-84aa-e053-2a91aa0a00292023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron8693b9fd-b048-84aa-e053-2a91aa0a00292023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron86937d85-7ffc-0992-e053-2a91aa0a7d0a2023-11-14Exact identifier
unii: E4GA8884NN
Phosphoricum acidumPHOSPHORIC ACIDBoiron8693180c-3b5b-27eb-e053-2a91aa0a18e22023-11-13Exact identifier
unii: E4GA8884NN
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: E4GA8884NN
BHI MigraineACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDEMediNatura Inc11cad8ba-6914-420e-bab0-4ca37d33f2e62023-09-28WarningsExact identifier
unii: E4GA8884NN
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: E4GA8884NN
TobaccostatAVENA SATIVA, VALERIANA OFFICINALIS, CAPSICUM ANNUUM, PAULLINIA SORBILIS, LOBELIA INFLATA, TABACUM, CADMIUM SULPHURATUM, CALADIUM SEGUINUM, DAPHNE INDICA, NUX VOMICA, PHOSPHORICUM ACIDUM, SPIGELIA ANTHELMIA, STAPHYSAGRIAEnergique, Inc.5f4ad1d8-4efb-4660-bab7-4fb05ff4f9092023-08-28WarningsExact identifier
unii: E4GA8884NN
PancreaparSYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMEnergique, Inc.99a4560e-f124-4569-a2f1-78ce5995f8e02023-08-24WarningsExact identifier
unii: E4GA8884NN
PancreaparSYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMEnergique, Inc.ba9c13d0-92de-4159-8a35-215e3de50c072023-08-24WarningsExact identifier
unii: E4GA8884NN
V HPARSENICUM ALBUM, BELLADONNA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOXEnergique, Inc.61e1a347-fd21-4065-940d-1cc42006d9a72023-08-23WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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