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
Label	Manufacturer	Effective date	Type
Xenleta	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	2024-10-11	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72000-030-06	2024-10-11	C162847	48780-1	1e7a6dab-19be-a2ce-e063-dadaa90aadf7	These 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
72000-030-06	2024-07-30	C162847	48780-1	1e7a6dab-19be-a2ce-e063-dadaa90aadf7	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
72000-030-01	Citric Buffered Normal Saline	270 mL in 1 BAG	INJECTION, SOLUTION	270		9
72000-030-06	Citric Buffered Normal Saline	6 in 1 CARTON	INJECTION, SOLUTION	6		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72000-030	XENLETA (LEFAMULIN ACETATE) INJECTION, SOLUTION CITRIC BUFFERED NORMAL SALINE (ANHYDROUS CITRIC ACID) INJECTION, SOLUTION XENLETA (LEFAMULIN ACETATE) TABLET, COATED [NABRIVA THERAPEUTICS US, INC.]	9	Legacy NDC, 2 package rows	20241013_101db63d-2fe2-48df-8506-1382d6dcd4a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72000-030-01	ML - Milliliter	72000-030	ba29e0ce-1f82-4fe4-bf76-56b490a40b81	1	2019-10-07
72000-030-06	ML - Milliliter	72000-030	3217de5e-71f1-4fa1-b2ff-7439fff9b8c8	1	2019-10-07

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 51 of 81 · 1,614 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XS H2O Liquescence	VALERIANA OFFICINALIS, CITRICUM ACIDUM, POTASSIUM BITARTRATE, ALLIUM SATIVUM, ARTERIA SUIS, CEREBRUM SUIS, KIDNEY (SUIS) RAUWOLFIA SERPENTINA, ADRENOCORTICOTROPHIN	Nutritional Specialties, Inc.	16a266cd-79cc-4f1d-839c-45183107e82c	2024-10-31	Warnings	Exact identifier unii: XF417D3PSL
Vaccistat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUM	Energique, Inc.	8c8d63b6-763a-44f8-87ef-e83a89ec3776	2024-10-31	Warnings	Exact identifier unii: ETJ7Z6XBU4 unii: 451W47IQ8X
Vaccistat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUM	Energique, Inc.	5205cc3e-c9bc-48e9-9c9b-959a9be78b85	2024-10-31	Warnings	Exact identifier unii: ETJ7Z6XBU4 unii: 451W47IQ8X
Weed Grass Antigens	ALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,	Energique, Inc.	0ec09d62-07ca-4bbe-9019-1025f5713211	2024-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Thyroid Tonic	ACACIA ARABICA, OLEUM OLEA EUROPAEA, SESAME OIL, FUCUS VESICULOSUS 3X, IODIUM, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAGE OIL, CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), HYDROFLUORICUM ACIDUM	Energique, Inc.	aeca8e0e-12e6-44d0-a709-401d137f7cf3	2024-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Silicea	SILICEA	Energique, Inc.	7ac17e38-d6e2-4cc9-8fcb-cbfa0d60223b	2024-10-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Scarstat	CALENDULA OFFICINALIS, GRAPHITES, HYPERICUM PERFORATUM, SILICEA, STAPHYSAGRIA, THIOSINAMINUM	Energique, Inc.	1decc2eb-1261-46b8-908e-a152535b4a02	2024-10-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Spleenex VH	ARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUS	Energique, Inc.	54e2c88e-2483-4c38-86e5-19e218e713ae	2024-10-30	Warnings	Exact identifier unii: XF417D3PSL
Spleenpar	SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS	Energique, Inc.	f89581c5-faab-42b2-b984-e369f6ff8b49	2024-10-30	Warnings	Exact identifier unii: 451W47IQ8X
SILICEA	SILICEA	Energique, Inc.	395f400d-6a87-4da9-aa1f-edca9729f1ac	2024-10-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Scrophulous HP	BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, GNAPHALIUM POLYCEPHALUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEA	Energique, Inc.	e50eb26b-6843-4b8f-8ea5-3d5f57a3e7b4	2024-10-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Spleenex V	ARALIA QUINQUEFOLIA, POTASSIUM GLUCONATE, GINKGO BILOBA, MAGNESIUM GLUCONICUM DIHYDRICUM, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ACONITICUM ACIDUM, CIS-, NATRUM OXALACETICUM	Energique, Inc.	effbaa07-239b-42f2-afd4-0eeeba7de1fd	2024-10-30	Warnings	Exact identifier unii: XF417D3PSL
Muscle/Tendon Pain and Stress Relief	CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)	Energique, Inc.	4a8f73ab-77af-4556-8bf2-96b5f5d3fb8f	2024-10-29	Warnings	Exact identifier unii: 451W47IQ8X
Chavita 1	CARBO VEG, OOPHORINUM, SILICEA, OLIBANUM, ORCHITINUM, URTICA URENS	RUBIMED AG	0ade088f-0ff2-4894-9aed-d0b0cfdde38d	2024-10-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Nat Mur	NATRUM MURIATICUM	Energique, Inc.	39c4cb25-e70f-4d5a-b7b6-1b62527aa4f3	2024-10-29	Warnings	Exact identifier unii: 451W47IQ8X
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Fresenius Kabi USA, LLC	68cc9c41-ed24-4f76-8efb-2936ae3ddd8d	2024-10-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Psora Miasm	EGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, FAGOPYRUM ESCULENTUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUM	Energique, Inc.	d008a091-b7c6-41f1-a1cf-f8224ebe55e5	2024-10-29	Warnings	Exact identifier unii: 451W47IQ8X
Pulmopar	LOBELIA INFLATA, LUNG (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BLATTA ORIENTALIS, BRYONIA (ALBA), PHOSPHORUS, SILICEA, SULPHUR	Energique, Inc.	1cfb69c5-dc01-4acc-8053-5ca4e64165dc	2024-10-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Multi-Cell Salt	KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEA	Energique, Inc.	dad00225-b3ac-4e36-a856-19b0faf42c42	2024-10-29	Warnings	Exact identifier unii: ETJ7Z6XBU4 unii: 451W47IQ8X
Recovatone	GLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,	Energique, Inc.	38fd4f98-a42a-435b-9643-16df66453951	2024-10-29	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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