FDA.reportPublic FDA data

NDC 72000-030-01 - Xenleta

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
72000-030
Requested NDC
72000-030-01
Package NDCs from labels
72000-030-01, 72000-030-06
Manufacturer
Nabriva Therapeutics US, Inc. | Nabriva Therapeutics Ireland DAC | Hovione Limited | Charles River Endotoxin Microbial Detection Europe | HOVIONE FARMACIENCIA, S.A. | Patheon Italia S.p.A | Almac Pharma Services Limited | Sharp Packaging Services, LLC
Effective date
2024-10-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XenletaNabriva Therapeutics US, Inc. | Nabriva Therapeutics Ireland DAC | Hovione Limited | Charles River Endotoxin Microbial Detection Europe | HOVIONE FARMACIENCIA, S.A. | Patheon Italia S.p.A | Almac Pharma Services Limited | Sharp Packaging Services, LLC2024-10-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72000-030-062024-10-11C16284748780-11e7a6dab-19be-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use XENLETA ® safely and effectively. See full prescribing information for XENLETA. XENLETA (lefamulin) injection, for intravenous use XENLETA (lefamulin) tablets, for oral use Initial U.S. Approval: 2019
72000-030-062024-07-30C16284748780-11e7a6dab-19be-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use XENLETA ® safely and effectively. See full prescribing information for XENLETA. XENLETA (lefamulin) injection, for intravenous use XENLETA (lefamulin) tablets, for oral use Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72000-030-01Citric Buffered Normal Saline270 mL in 1 BAGINJECTION, SOLUTION2709
72000-030-06Citric Buffered Normal Saline6 in 1 CARTONINJECTION, SOLUTION69

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72000-030XENLETA (LEFAMULIN ACETATE) INJECTION, SOLUTION CITRIC BUFFERED NORMAL SALINE (ANHYDROUS CITRIC ACID) INJECTION, SOLUTION XENLETA (LEFAMULIN ACETATE) TABLET, COATED [NABRIVA THERAPEUTICS US, INC.]9Legacy NDC, 2 package rows20241013_101db63d-2fe2-48df-8506-1382d6dcd4a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72000-030-01ML - Milliliter72000-030ba29e0ce-1f82-4fe4-bf76-56b490a40b8112019-10-07
72000-030-06ML - Milliliter72000-0303217de5e-71f1-4fa1-b2ff-7439fff9b8c812019-10-07

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 52 of 81 · 1,614 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.Energique, Inc.76c6b494-43d1-4508-bea4-4f9026b4a5fa2024-10-29WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 30XSILICON DIOXIDETrue Botanica, LLC1d99c26a-3f95-c138-e063-6294a90a9d622024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmuparARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEAEnergique, Inc.8b01e718-83b7-4f93-8fea-d0e37c7561852024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
DERMATOME HPLYCOPODICUM CLAVATUM, MEZEREUM, NATRUM MURIATICUM,Energique, Inc.54a096ac-7ebe-4565-b1b0-0473de16e70c2024-10-24WarningsExact identifier
unii: 451W47IQ8X
FATIGUE NOSODE EBASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODEEnergique, Inc.36d963cc-fd47-40ee-aa73-c2e7fcedf1922024-10-24WarningsExact identifier
unii: ETJ7Z6XBU4
Complexion HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMEnergique, Inc.ad12d51e-04cb-4833-b802-0038796966ff2024-10-24WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
CV HPADONIS VERNALIS, LACHESIS MUTUS, LYCOPUS VIRGINICUS, VALERIANA OFFICINALIS, AURUM METALLICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS),ENERGIQUE, INC.c06763c5-8bde-4251-bd41-67becf8ce8c42024-10-24WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.2af0dc7b-5f8b-44fa-9589-bc95043428e92024-10-24WarningsExact identifier
unii: 451W47IQ8X
OratoxFUCUS VESICULOSUS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA MURIATICA, IODIUM, NATRUM FLUORATUM, NATRUM MURIATICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.b78d8991-ffbe-4b11-b9b9-8fe432bed8aa2024-10-23WarningsExact identifier
unii: 451W47IQ8X
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.a631a250-d6d8-479c-a53e-347ac908c5ff2024-10-22WarningsExact identifier
unii: 451W47IQ8X
MetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: 451W47IQ8X
RhustoxoforceAPIS MELLIFICA, CANTHARIS, GRAPHITES, NATRUM MURIATICUM, RHUS GLABRA, RHUS TOXICODENDRON, RHUS VENENATA, URTICA DIOICABioActive Nutritional, Inc.5a3627f1-a850-42f3-8c7a-b2067bd035382024-10-18WarningsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBecton Dickinson and Companybb2ad9cd-5d9a-4337-be61-0842d738c79e2024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC8fce1477-991f-4b43-bf05-a80bad8972622024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc44b0fdb-33df-4747-b443-5fb4deb456cb2024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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