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 45 of 81 · 1,614 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-68CROTON OIL, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.01ae098b-aadd-4edc-bf73-6bc60903e7792025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-53AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTADNA Labs, Inc.3787d569-ee4d-41de-9519-73c11b626b382025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-51ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATEDNA Labs, Inc.9928dd54-bd3a-47cb-bde5-4bebab3db6832025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-132SILICON DIOXIDEDNA Labs, Inc.3d8e499d-ebe2-45b9-b078-256268c42d4b2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-117ATROPA BELLADONNA AND SILICON DIOXIDEDNA Labs, Inc.8bcce284-f8f3-4d62-a13e-b93c2c655a702025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-109ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLEDNA Labs, Inc.7758341d-e0be-487a-ba47-8847551231e12025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Incbe0da1f0-06a1-11df-8a39-0800200c9a662025-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 451W47IQ8X
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
A-36BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAFDNA Labs, Inc.161c4738-9ead-4687-9f5a-029d5a496e072025-01-09WarningsExact identifier
unii: 451W47IQ8X
AM-9SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLEDNA Labs, Inc.d7a00f0b-de4c-4bff-b8e0-86a82bed8bb92025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
AM-11ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERADNA Labs, Inc.c072811b-6259-4b22-b364-50369dc68fb02025-01-09WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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