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 8 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-40PHOSPHORIC ACID, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, CLAVICEPS PURPUREA SCLEROTIUM, URANYL NITRATE HEXAHYDRATE, PHASEOLUS VULGARIS WHOLE, AND ARSENIC TRIOXIDEDNA Labs, Inc.8a86c0ee-93e9-48da-a7d8-89225e2331772025-01-13WarningsExact identifier
unii: E4GA8884NN
D-41PHOSPHORIC ACID, CHASTE TREE, CINCHONA OFFICINALIS BARK, TURNERA DIFFUSA LEAFY TWIG, PHOSPHORUS, SEPIA OFFICINALIS JUICE, BOS TAURUS TESTICLE, AND CONIUM MACULATUM FLOWERING TOPDNA Labs, Inc.3600d04a-bab5-440a-a2aa-908bf920620a2025-01-13WarningsExact identifier
unii: E4GA8884NN
D-120CALCIUM FLUORIDE, BISMUTH SUBNITRATE, ZINC, MERCURIC CHLORIDE, TOXICODENDRON PUBESCENS LEAF, ANTIMONY TRISULFIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, IODINE, PHOSPHORIC ACID, POTASSIUM CARBONATE, DIBASIC POTASSIUM PHOSPHATE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.9525c016-f0dd-43fd-a4e9-062075107eec2025-01-13WarningsExact identifier
unii: E4GA8884NN
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Incbe0da1f0-06a1-11df-8a39-0800200c9a662025-01-10WarningsExact identifier
unii: E4GA8884NN
AM-14SILVER, CALCIUM IODIDE, LYTTA VESICATORIA, COPPER, FERROUS IODIDE, GOLDENSEAL, IODINE, DAPHNE MEZEREUM BARK, PHOSPHORIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, AND RUMEX CRISPUS WHOLEDNA Labs, Inc.8bf2fde6-fd71-47f8-b5ec-c5e34857ab642025-01-09WarningsExact identifier
unii: E4GA8884NN
N-11CINCHONA OFFICINALIS BARK, PHOSPHORIC ACID, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS ADRENAL GLAND, SUS SCROFA TESTICLE, AND BOS TAURUS PROSTATE GLANDDNA Labs, Inc.74b694d7-448d-4509-8bc5-fb1eadca9b252025-01-09WarningsExact identifier
unii: E4GA8884NN
N-12PHOSPHORIC ACID, CINCHONA OFFICINALIS BARK, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VIBURNUM OPULUS WHOLE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS OVARY, BOS TAURUS ADRENAL GLAND, AND THYROID, UNSPECIFIEDDNA Labs, Inc.89ed00b4-5739-439e-bae9-e00b0b0d72222025-01-09WarningsExact identifier
unii: E4GA8884NN
N-26BARIUM CHLORIDE DIHYDRATE, CONIUM MACULATUM WHOLE, ARNICA MONTANA, PHOSPHORIC ACID, DIBASIC POTASSIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, AND PORK BRAINDNA Labs, Inc.3fb35088-9c43-411f-992f-43b88ff239152025-01-09WarningsExact identifier
unii: E4GA8884NN
N-27ARNICA MONTANA, MILK THISTLE, SUS SCROFA CEREBRUM, CINCHONA OFFICINALIS BARK, GINKGO BILOBA WHOLE, LECITHIN, SOYBEAN, LITHIUM CARBONATE, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, PORK BRAIN, ALNUS GLUTINOSA WHOLE, AND ROSMARINUS OFFICINALIS FLOWERING TOPDNA Labs, Inc.df2d7683-3b45-4ddb-9b67-7bb74dad28542025-01-09WarningsExact identifier
unii: E4GA8884NN
Emetrol Children Mixed BerryPHOSPHORATED CARBOHYDRATEWellSpring Pharmaceutical Corporationecff699b-d4d8-4407-8119-3e9a1100024a2025-01-08WarningsExact 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.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: E4GA8884NN
FNGADENOSINUM TRIPHOSPHORICUM DINATRUM, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, BERBERIS VULGARIS, BRUGIA MALAYI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CARBOLICUM ACIDUM, COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, FORMALINUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, IRIDIUM METALLICUM, LOMATIUM DISSECTUM, LYCOPODIUM CLAVATUM, METHYLCOBALAMIN, MUCOR RACEMOSUS, MUTABILE BACILLUS (BACH), MYRRHA, PHOSPHORICUM ACIDUM, PROPOLIS, PULSATILLA (PRATENSIS), RHIZOPUS NIGRICANS,Deseret Biologicals, Inc.475f5338-7945-4a71-801b-01b1a21f98602024-11-20WarningsExact 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, X-RAY, URANIUM NITRICUMBioActive Nutritional17229a97-4712-49dc-8208-26a585ba54322024-11-14WarningsExact identifier
unii: E4GA8884NN
Vital Brain EnergyARNICA MONTANA, CARDUUS MARIANUS, CEREBRUM SUIS, CINCHONA OFFICINALIS, GINKGO BILOBA, LECITHIN, MILLEFOLIUM, PHOSPHORICUM ACIDUMLiddell Laboratories, Inc.39446d61-bf75-44d1-8291-55c37911e21f2024-11-04WarningsExact identifier
unii: E4GA8884NN
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: E4GA8884NN
Spleenex VHARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.54e2c88e-2483-4c38-86e5-19e218e713ae2024-10-30WarningsExact identifier
unii: E4GA8884NN
SpleenparSPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUSEnergique, Inc.f89581c5-faab-42b2-b984-e369f6ff8b492024-10-30WarningsExact identifier
unii: E4GA8884NN
PostpituaparAPIS MELLIFICA, ARSENICUM ALBUM, LACHESIS MUTUS, NUX VOMICA, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), PULSATILLA (PRATENSIS), SAMBUCUS NIGRA, THUJA OCCIDENTALISEnergique, Inc.1212410f-ebe9-40b8-85f6-27bd45456e4a2024-10-29WarningsExact identifier
unii: E4GA8884NN
IndustristatPLANTAGO MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CADMIUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMEnergique, Inc.1279a90c-6263-4ca6-87e1-4b31a36854bb2024-10-28WarningsExact identifier
unii: E4GA8884NN
Premier Value Nausea Control Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDPHARMACY VALUE ALLIANCE, LLC8f000438-a9c3-45ca-8cb5-79151b2b3ead2024-10-28WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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