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 63 of 78 · 1,548 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff604442-4697-e2bb-e053-6394a90a0340	2023-06-30	Warnings	Exact identifier unii: 451W47IQ8X
Kidney Drainage	SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM	Deseret Biologicals, Inc.	4f82e261-6101-48ab-b161-ded5aa41cd85	2023-06-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86455058-2722-5c0a-e053-2a91aa0ac659	2023-06-26		Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fecece1f-22bc-21dc-e053-6294a90ad0c3	2023-06-23	Warnings	Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fed03a1c-0ea8-1f8e-e053-6394a90a04c0	2023-06-23	Warnings	Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	febf610e-e08a-4797-e053-6294a90a3eb5	2023-06-22	Warnings	Exact identifier unii: 451W47IQ8X
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	7a2d8dab-750f-43c1-933c-4169a840c60c	2023-06-20	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Grain and Seed Antigens	AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR	BioActive Nutritional, Inc.	36ce44a5-e5ac-4eea-b76d-424dcd4e6b07	2023-06-20	Warnings	Exact identifier unii: 451W47IQ8X
Vital Skin Hair Nails	L-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALIS	Liddell Laboratories, Inc.	3e8a9233-6e65-4023-b3f8-8bca369a9c2a	2023-06-15	Warnings	Exact identifier unii: 451W47IQ8X
Calciforce	ARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICA	BioActive Nutritional, Inc.	1609ce3e-82c2-4597-86e6-847c944ddbe6	2023-06-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
Endopar F	CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA	Energique, Inc.	d186ae0e-0dc3-48e7-9e22-6778bb80ad18	2023-06-07	Warnings	Exact identifier unii: 451W47IQ8X
Silicea 6X	SILICEA 6X	True Botanica, LLC	fd296871-c491-7d30-e053-6294a90ab64d	2023-06-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
LY-CO	ANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTRE	Bhp Holdings, Inc.	47140966-5b49-432d-bf35-bcae14f42082	2023-06-01	Warnings	Exact identifier unii: XF417D3PSL
Lyme and Co-Infection Nosode	ANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BABESIA MICROTI, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTRE	Bhp Holdings, Inc.	f6186157-256f-4454-b122-f7665e3286f4	2023-06-01	Warnings	Exact identifier unii: XF417D3PSL
Cyclease PMS	ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE	Laboratoires Boiron	09ff0633-2992-4aba-96ed-45a69f3ee589	2023-05-30	Warnings	Exact identifier unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDE	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	8a0d24a9-d02a-0379-e053-2a95a90af712	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Bacteriostatic Water	WATER	Medical Purchasing Solutions, LLC	69485218-9343-952d-e053-2a91aa0ad4e8	2023-05-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Histastat Pollen	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDES	Energique, Inc.	00478787-ccec-4101-a0da-fd337037c3ee	2023-05-12	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	STERILE WATER	Hikma Pharmaceuticals USA Inc.	b20a28b0-7dfa-42eb-9177-ec256d5a5ef7	2023-05-08	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Natrum Muriaticum	NATRIUM MURIATICUM	True Botanica, LLC	7d2d9129-8683-484d-e053-2a91aa0a6f8f	2023-05-01	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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