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 5 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Woman PowerAGNUS, ARALIA QUIN, ARNICA, DAMIANA, LACTUCA, NAT MUR, ONOSMODIUM VIRGINIANUM, OOPHORINUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SALIX NIG, SEPIA, THUJA OCCEight and Company L.L.C614d47de-742b-4944-89c8-59f2f58dc8b92025-12-17WarningsExact identifier
unii: E4GA8884NN
MoodARALIA QUIN, CIMICIFUGA, SPIGELIA ANTH, ARG NIT, ARSENICUM ALB, AURUM MET, IGNATIA AMARA, LACHESIS, LYCOPODIUM, NAT MUR, PHOSPHORICUM AC, PLATINUM MET, PULSATILLA, SEPIA, THUJA OCCNatural Creations, Inc7f143f30-2b72-4e6c-985c-8d3a485dbdb42025-12-16WarningsExact identifier
unii: E4GA8884NN
PanacodeSYZYGIUM, HYDRASTIS, ADRENALINUM, PANCREATINUM, PITUITARUM POSTERIUM, BOVISTA, INSULIN, LYCOPERSICUM, PHOSPHORICUM AC, PHOSPHORUS, TARENTULA HISPANA, TEREBINTHINA, URANIUM NITRICUMNatural Creations, Incf2144c14-28a2-4dc4-b517-0f81e9c8b7202025-12-16WarningsExact identifier
unii: E4GA8884NN
Chronic Fatigue TherapyEPINEPHRINE, GOLD, CHELIDONIUM MAJUS, ECHINACEA, GINKGO, HELLEBORUS NIGER, PHOSPHORIC ACID, SCUTELLARIA LATERIFLORA, THUJA OCCIDENTALISTRP Company751334b8-f21b-3f94-e053-2a91aa0a9bb92025-12-15WarningsExact identifier
unii: E4GA8884NN
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: E4GA8884NN
Anti Nausea Liquid Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)743b215a-81cc-408c-9375-4f427161a05b2025-12-04WarningsExact identifier
unii: E4GA8884NN
QUALITY CHOICE Anti-NauseaDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)68207fa3-3f69-4405-9191-be702e1bf5202025-12-04WarningsExact identifier
unii: E4GA8884NN
Walgreen Anti Nausea Cherry FlavorPHOSPHORATED CARBOHYDRATEWALGREENS CO.69e72d30-feca-454d-addc-8ed7325568d32025-12-01WarningsExact identifier
unii: E4GA8884NN
Candida HPBAPTISIA TINCTORIA ROOT, ECHINACEA PURPUREA, GLYCYRRHIZA GLABRA, ASTRAGALUS NUTTALLII LEAF, CANDIDA ALBICANS, SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, WOOD CREOSOTE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, NITRIC ACIDNatural Creations, Inc.b587a3f0-628b-41f7-8afb-2cdcd896279e2025-11-20WarningsExact identifier
unii: E4GA8884NN
Vital Male Sexual EnergyARNICA MONTANA, AVENA SATIVA, CALADIUM SEGUINUM, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, NUPHAR LUTEUM, ORCHITINUM, PANAX GINSENG, PHOSPHORICUM ACIDUM, POPULUS TREMULOIDES, TESTOSTERONE, THUJA OCCIDENTALIS, THYMUS SUIS, THYROIDINUM SUISLiddell Laboratories, Inc.7467edf6-50a2-4773-83e2-d266c23e63982025-11-20WarningsExact identifier
unii: E4GA8884NN
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: E4GA8884NN
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
Natural Relief Diarrhea ReliefALOE, CITRULLUS COLOCYNTHIS, CROTON TIGLIUM, LYCOPODIUM CLAVATUM, MAGNESIUM SULFATE HEPTAHYDRATE, PHOSPHORIC ACID, THUJA OCCIDENTALISTRP Company436de0c5-acd6-e32b-e063-6394a90aa2752025-11-12WarningsExact identifier
unii: E4GA8884NN
Anti Nausea LiquidPHOSPHORATED CARBOHYDRATETOPCO ASSOCIATES LLCfd0e8feb-89b5-42ff-806a-55b7473cf5872025-11-10WarningsExact identifier
unii: E4GA8884NN
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Anti NauseaDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDRUGBY LABORATORIES8506b4ab-a19e-4b0d-aa98-143bf75a11712025-10-25WarningsExact identifier
unii: E4GA8884NN
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Anti NauseaDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDCardinal Healthb2f0e93f-a2e9-4970-bfb8-de30a62478132025-10-14WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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