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 40 of 81 · 1,614 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM253CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products2fa9913f-0593-f77b-e063-6394a90ab6b22025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM254APIS MEL, BRYONIA, GELSEMIUM, NAT MUR, PULSATILLABestmade Natural Products2fa9bb2c-848b-06ef-e063-6394a90ad0f02025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNATRUM MURIATICUMBestmade Natural Products2fa9f3a3-91e3-2f8e-e063-6294a90afda82025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products SiliceaSILICEABestmade Natural Products2fabb037-5f94-cbb4-e063-6294a90a7b832025-03-06WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM231ABROTANUM, ANTI IOD, ARSENIC IOD, BARYTA CARB, CALC PHOS, FERR MET, KALI IOD, SILICEABestmade Natural Products2f81507c-b5b0-a976-e063-6394a90a869e2025-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM237BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEABestmade Natural Products2f82f2c4-a549-9e17-e063-6394a90aea812025-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM244CALC CARB, CALC PHOS, CARBO VEG, NAT MUR, PHYSOSTIGMA, RUTA GRAV.Bestmade Natural Products2f853410-e831-90ce-e063-6394a90a26b12025-03-04WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA, GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, CINCHONA OFFICINALIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.5254181b-188e-4ef2-b91e-15e87e31de702025-02-26WarningsExact identifier
unii: 451W47IQ8X
SiliceaSILICON DIOXIDEWashington Homeopathic Products2ee71a08-f69b-e2ef-e063-6394a90ab9902025-02-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM186ARNICA, FERR. PHOS, IGNATIA, SILICA, HYPERICUMBestmade Natural Products2e9437ae-59fa-c646-e063-6294a90ac0f62025-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM188ALLIUM CEPA, AMBROSIA ARTEMISIA, GELSEMIUM, KALI BICHROME, NAT MUR, SABADILLABestmade Natural Products2e950192-e5cf-37b4-e063-6394a90a1e9a2025-02-20WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM168CONIUM, PILOCARPINE MURIATE, KALI SIL, KALI ARS, SULPHUR, NAT MURBestmade Natural Products2e7bc230-8a37-9975-e063-6294a90a15e72025-02-19WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM173ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBestmade Natural Products2e7de086-a4c1-ae9e-e063-6394a90aa5f52025-02-19WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
Bestmade Natural Products BM146ACID SULPH, APIS MELL, ARNICA MONT, CALENDULA OFF, HAMAMELIS, IODIUM, LYCOPODIUM, SILICEABestmade Natural Products2e69161f-e4e2-a5cc-e063-6394a90a476f2025-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Aurum HypericumAURUM HYPERICUMUriel Pharmacy, Inc2df4f968-af1d-82f1-e063-6294a90a65be2025-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
NATRUM MURIATICUM 200ckNATRUM MURIATICUMSEVENE USAcf892234-de72-37e1-e053-2995a90a1c392025-02-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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