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
Label	Manufacturer	Effective date	Type
Orbactiv	The Medicines Company \| AndersonBrecon Inc. \| AbbVie Inc. \| Patheon Italia S.p.A. \| Carton Service, Incorporated	2020-02-18	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65293-015-03	2020-02-11	C162847	48780-1	9d75b9d0-8e03-f424-e053-dadaa90a57ce	These 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
65293-015-03	2020-01-31	C162847	48780-1	9d75b9d0-8e03-f424-e053-dadaa90a57ce	These 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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65293-015-01	EA - Each	65293-015	5ab086a2-37f6-4c93-900d-074b4c2b2b81	1	2014-10-03
65293-015-03	EA - Each	65293-015	fbc9c6e5-6131-4d1f-9899-57f1991b86f7	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ORITAVANCIN	ACTIVE INGREDIENT	PUG62FRZ2E	ORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]	2
ORITAVANCIN	ACTIVE MOIETY	PUG62FRZ2E	ORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]	2
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	ORBACTIV (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 15 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
G7 Flex	ARNICA MONTANA, CARDUUS MARIANUS, HEPAR SUIS, HYPOPHYSIS SUIS, PANAX GINSENG, PHOSPHORICUM ACIDUM	Safe Anabolic Sciences	de2d95b7-edca-41cd-9fd3-a98c124756d8	2018-05-04	Warnings	Exact identifier unii: E4GA8884NN
Immuno Fortifier	ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEA	BioActive Nutritional, Inc.	04024663-0b11-438a-a21a-8e86edd8052a	2018-01-15	Warnings	Exact identifier unii: E4GA8884NN
H7 Complex	ARNICA MONTANA, CARDUUS MARIANUS, HEPAR SUIS, HYPOPHYSIS SUIS, PANAX GINSENG, PHOSPHORICUM ACIDUM	Maximum Results Solution, Inc.	386fba2d-1523-4e4b-b0ab-7981523c65ab	2017-11-29	Warnings	Exact identifier unii: E4GA8884NN
Homeoplex A	ARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, ARSENICUM IODATUM, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUM	Supplement Clinic, LLC.	fee279bf-76b7-4a84-ac8c-cd2489a910fb	2017-11-01	Warnings	Exact identifier unii: E4GA8884NN
Homeoplex D	GLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,	Supplement Clinic, LLC.	cd6b48ab-3566-484d-8deb-15ef6f8e7e8f	2017-11-01	Warnings	Exact identifier unii: E4GA8884NN
Spleen-Pro T018	SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS	Guangzhou Renuma Medical Systems Co., Ltd	bc2b70bd-2a4a-46fb-b3d8-d69b61056b89	2017-10-26	Warnings	Exact identifier unii: E4GA8884NN
Glucose Control T015	SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUM	Guangzhou Renuma Medical Systems Co., Ltd	3fd02c0a-5cf1-4f35-86d0-d5d09e63f39b	2017-10-26	Warnings	Exact identifier unii: E4GA8884NN
Industrotox	GLYCYRRHIZA GLABRA, PLANTAGO MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ARNICA MONTANA, ASCLEPIAS TUBEROSA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, LAPPA MAJOR, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, SYMPHYTUM OFFICINALE, HEPAR SUIS, LUNG (SUIS), LYMPH NODE (SUIS)	BioActive Nutritional, Inc.	0722085a-1478-4667-b0c6-3315cff25b08	2017-06-16	Warnings	Exact identifier unii: E4GA8884NN
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM	Energetix Corp	6b0d1628-b20d-426e-9c84-5cceadca3f45	2016-11-11	Warnings	Exact identifier unii: E4GA8884NN
Food Additives	BERBERIS VULGARIS, CHELIDONIUM MAJUS, TRIFOLIUM PRATENSE, GLYCYRRHIZA GLABRA, LAPPA MAJOR, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, XANTHOXYLUM FRAXINEUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM	BioActive Nutritional, Inc.	bf27d457-12e1-4ab6-b132-1b65cde0ed93	2016-09-28	Warnings	Exact identifier unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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