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 7 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products Hair SupportACID PHOS, ARNICA MONT, ARS ALB, GRAPHITES, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURBestmade Natural Products303c529d-b946-8e06-e063-6394a90af2b42025-03-13WarningsExact identifier
unii: E4GA8884NN
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: E4GA8884NN
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM187ACID PHOS, ARSEN IOD, CEANOTHUS AMERIC, CHINA OFF, FERRUM MUR, LYCOPODIUMBestmade Natural Products2e948f46-740e-0543-e063-6394a90afd732025-02-20WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM142ACID PHOS, ARNICA MONT, CICHORIUM INTY, ECHINACEA ANG, GINSENG, PAEONIA OFF, SARSAPARILLA, SULPHUR, TRITICUM REP, URTICA URENSBestmade Natural Products2e682051-2d61-1578-e063-6394a90a5e992025-02-18WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM164ACID PHOS, ARUM TRYPH, BALSAMUM PERU, CAUSTICUM, EQUISETUM, GLYCERINUM, HELONIAS DIOBestmade Natural Products2e6e49aa-278e-5499-e063-6394a90a999c2025-02-18WarningsExact identifier
unii: E4GA8884NN
Aurum HypericumAURUM HYPERICUMUriel Pharmacy, Inc2df4f968-af1d-82f1-e063-6294a90a65be2025-02-12WarningsExact identifier
unii: E4GA8884NN
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d22bedb-9f9d-8421-e053-2a95a90acf4a2025-02-10WarningsExact identifier
unii: E4GA8884NN
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d23e5da-4806-8ccc-e053-2995a90a19012025-02-10WarningsExact identifier
unii: E4GA8884NN
PrimeGINKGO BILOBA, RUTA GRAVEOLENS, AGNUS CASTUS, ALLIUM SATIVUM, AMBRA GRISEA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, AVENA SATIVA, BAPTISIA TINCTORIA, BARYTA CARBONICA, BRYONIA, CANTHARIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PULSATILLA, RUTA GRAVEOLENS, SABAL SERRULATA, SELENIUM METALLICUM, ZINCUM METALLICUM.Newton Laboratories, Inc.9b40f630-0b91-9816-e053-2a95a90a16ec2025-02-10WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM105ACID PHOS, AGNUS CASTUS, CHINA OFF, DAMIANA, IKSHUGANDHA, USTILAGO, PHOSPHOROUSBestmade Natural Products2d8bc5e4-23c7-a3ec-e063-6394a90a280b2025-02-07WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM118ANACARDIUM ORI, ARSENIC ALB, AURUM MUR, KALI BROM, LYCOPODIUM, NATRUM CARB, NATRUM SULPH, PHOSPHORIC ACIDBestmade Natural Products2d90b08b-b65d-7d11-e063-6294a90a50922025-02-07WarningsExact identifier
unii: E4GA8884NN
Phosphoricum Acidum Kit RefillPHOSPHORIC ACIDWashington Homeopathic Products099254bb-7923-8887-e063-6294a90a2f2e2025-01-28WarningsExact identifier
unii: E4GA8884NN
Endopan HPACETICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, BRYONIA (ALBA), CHROMIUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, SYZYGIUM JAMBOLANUM, THUJA OCCIDENTALIS, URANIUM NITRICUMEnergique, Inc.2bc69a24-c24c-4d12-92bb-7c073edf90dc2025-01-24WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM33ACID FOLICD10, ACID PHOSD4, ARSENIC ALBD4, AVENA SATD3, BETA VULGD5, CHINA OFFD12, FERR METD5, NATRUM MURD5Bestmade Natural Productsef2beaff-5c94-de60-e053-2995a90ad7962025-01-23WarningsExact identifier
unii: E4GA8884NN
Bestmade Natural Products BM10ACID PHOSD12, NAT SULPHD7, LYCOPODIUMD4, SYZYGIUM JAMBOLD8, TARAXACUMD8, URANIUM NITD6, UVA URSID8Bestmade Natural Productsec588d4c-4bc4-3829-e053-2995a90ac6202025-01-22WarningsExact 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.61111d6e-2480-4e89-bb0e-d712f044bdc72025-01-20WarningsExact identifier
unii: E4GA8884NN
D-4QUININE ARSENITE, PHOSPHORIC ACID, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MERCURIC CHLORIDE, VERATRUM ALBUM ROOT, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, NERIUM OLEANDER LEAF, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.45577059-73f4-4302-b299-3e356aaf959a2025-01-13WarningsExact identifier
unii: E4GA8884NN
D-15ROSA CANINA FRUIT, ANAMIRTA COCCULUS SEED, PHOSPHORIC ACID, CHAMAELIRIUM LUTEUM ROOT, STRYCHNOS IGNATII SEED, ZINC, AND HONEYDNA Labs, Inc.0563477f-1e69-4e08-8c5c-527fe70965972025-01-13WarningsExact identifier
unii: E4GA8884NN
D-26FERROUS IODIDE, PHOSPHORIC ACID, SULFUR IODIDE, CALCIUM IODIDE, AND NITRIC ACIDDNA Labs, Inc.5ef26695-7b71-4c01-a60c-f72dd1fa342d2025-01-13WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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