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 3 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glucoseforce HPCOLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, URANIUM NITRICUMBioActive Nutritional, Inc.f1e89586-02ed-4b29-9902-12b17c01bee92026-03-09WarningsExact identifier
unii: E4GA8884NN
Good Mood EnhancerAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SEPIA, SINAPIS ARVENSIS, FLOS AND TABACUM.King Bio Inc.26150aa1-7729-4f64-a761-eab251f046e52026-03-06WarningsExact identifier
unii: E4GA8884NN
V Force HPARSENICUM ALBUM, BELLADONNA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOXBioActive Nutritional, Inc.415ce4af-40fa-4510-8b35-3da217c859f22026-03-06WarningsExact identifier
unii: E4GA8884NN
Bio Chem DetoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, TRITICUM AESTIVUM, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CARBO VEGETABILIS, CINCHONA OFFICINALIS, CONIUM MACULATUM, MERCURIUS CORROSIVUS, PHOSPHORUS, SULPHUR, TABACUM, NITRICUM ACIDUM, AGARICUS MUSCARIUS,BioActive Nutritional, Inc.3f9bd6c8-6fc9-4af1-8263-ab42f99fba372026-03-05WarningsExact identifier
unii: E4GA8884NN
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: E4GA8884NN
Multi-Strain Candida ReliefABIES CANADENSIS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ALOE, ANTIMONIUM CRUDUM, ASAFOETIDA, BORAX, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CARPINUS BETULUS, FLOS, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MALUS PUMILA, FLOS, OLEA EUROPAEA, FLOS, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, PULSATILLA, SABADILLA, STICTA PULMONARIA, SULPHUR AND THUJA OCCIDENTALISKing Bio Inc.02d4faa9-64e5-4d5a-9ba6-9d00a1d1e13f2026-03-02WarningsExact identifier
unii: E4GA8884NN
Focus, Comprehension and LearningAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, CALCAREA CARBONICA, IGNATIA AMARA, LECITHIN, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, OLEANDER, PHOSPHORICUM ACIDUM, RNA AND ZINCUM METALLICUM.King Bio Inc.b2a4dd82-7dd4-4dff-8a03-770f524bce1f2026-03-02WarningsExact identifier
unii: E4GA8884NN
LibidotoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, AGNUS CASTUS, AVENA SATIVA, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, HYPOPHYSIS SUIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, SEPIAEnergique, Inc.4ceacaa0-0219-421a-8fff-c1784c3d0f702026-02-27WarningsExact identifier
unii: E4GA8884NN
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: E4GA8884NN
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: E4GA8884NN
Vital Male Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CALADIUM SEGUINUM, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, NUPHAR LUTEUM, ORCHITINUM (SUIS), PANAX GINSENG, PHOSPHORICUM ACIDUM, TESTOSTERONE, THUJA OCCIDENTALIS, THYMUS (SUIS), THYROIDINUM (SUIS)Liddell Laboratories, Inc.5c9a9e1b-1145-4865-a983-fd808e85a1022026-01-29WarningsExact identifier
unii: E4GA8884NN
OHM-DAMAGNUS CASTUS, AVENA SATIVA, DAMIANA, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, LYCOPODIUM CLAVATUM, ORCHITINUM, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SELENIUM METALLICUM, TRIBULUS TERRESTRIS, YOHIMBINUMOHM PHARMA INC.e43b1786-86dd-4716-b066-e5fda25996302026-01-28WarningsExact identifier
unii: E4GA8884NN
FNG IECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, CONDURANGO, GINKGO BILOBA, LIGUSTICUM PORTERI, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (BOVINE), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SEPIA, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, TORULA CEREVISIAE, MUCOR RACEMOSUS, RHIZOPUS NIGRICANSBioActive Nutritional, Inc.41254429-adc9-4a5d-b956-156a9bf2cf772026-01-20WarningsExact identifier
unii: E4GA8884NN
WALGREEN CHILDREN ANTI NAUSEADEXTROSE, LEVULOSE, PHOSPHORIC ACIDWALGREENS CO.1c5659ec-100f-49c6-8f2c-58c14fc7dfed2026-01-16WarningsExact identifier
unii: E4GA8884NN
Sepia Combination 9246SEPIA COMBINATIONProfessional Complementary Health Formulasfe79986b-7b2d-4cfd-8386-45de02115ca92026-01-08WarningsExact identifier
unii: E4GA8884NN
Pancreas DB Liquescence 3037PANCREAS DB LIQUESCENCEProfessional Complementary Health Formulas30bc86e9-538b-449a-af48-99aafc4059242026-01-08WarningsExact identifier
unii: E4GA8884NN
Pineal/Pituitary/Hypothalamus Drops 5022PINEAL/PITUITARY/HYPOTHALAMUS DROPSProfessional Complementary Health Formulas97307e9b-5da3-40d3-a619-0722ca3069802026-01-08WarningsExact identifier
unii: E4GA8884NN
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: E4GA8884NN
Hyperhidrosis Drops 2144HYPERHIDROSIS DROPSProfessional Complementary Health Formulasbca49d5e-6ade-41d5-82f5-1551936d0a3b2026-01-08WarningsExact identifier
unii: E4GA8884NN
DNA Insulin Drops 2019DNA INSULIN DROPSProfessional Complementary Health Formulas527dbb62-5c68-4ea8-93c7-48122817d6a52026-01-08WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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