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 74 of 78 · 1,548 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fatigue Fighter	ACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.	Newton Laboratories, Inc.	9aa3c692-fbe0-debe-e053-2995a90add50	2020-11-25	Warnings	Exact identifier unii: 451W47IQ8X
Fatigue Fighter	ACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.	Newton Laboratories, Inc.	9ab1c9ba-a90e-7f55-e053-2a95a90a9451	2020-11-25	Warnings	Exact identifier unii: 451W47IQ8X
Feminine Comfort	AGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELIS	Newton Laboratories, Inc.	9ab4520d-1dd3-7b9f-e053-2a95a90a274f	2020-11-25	Warnings	Exact identifier unii: 451W47IQ8X
Acne	ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM	Newton Laboratories, Inc.	798c853c-16ab-8502-e053-2a91aa0a6532	2020-11-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Acne	ANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUM	Newton Laboratories, Inc.	798d5f34-819a-9895-e053-2991aa0a1d62	2020-11-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	79890e75-dfac-0262-e053-2a91aa0a5ce5	2020-11-24	Warnings	Exact identifier unii: 451W47IQ8X
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	798ab5a2-7464-8e9d-e053-2a91aa0acc98	2020-11-24	Warnings	Exact identifier unii: 451W47IQ8X
Breast Care	BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM	Newton Laboratories, Inc.	79edde91-f909-f7b3-e053-2991aa0a9d1c	2020-11-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Cold Hands - Feet	HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA	Newton Laboratories, Inc.	7a2b4f28-2128-a8b2-e053-2a91aa0a2402	2020-11-24	Warnings	Exact identifier unii: 451W47IQ8X
Constipation	ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM	Newton Laboratories, Inc.	90807700-3099-850c-e053-2995a90ada55	2020-11-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Constipation	ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM	Newton Laboratories, Inc.	90804a94-1e67-3ab3-e053-2a95a90aafbe	2020-11-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Post - Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	9042b7ad-15ed-0e81-e053-2a95a90afe28	2020-11-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
Post-Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	90bb15e5-3d9d-e2e2-e053-2995a90a85ac	2020-11-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	Asclemed USA, Inc.	afac6cc5-1ced-4639-b6f6-86f40ef5c30e	2020-10-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
GUNA ALLERGY	ADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -	Guna spa	ae6bd80d-2c70-1a3f-e053-2a95a90a2652	2020-10-23	Warnings	Exact identifier unii: 451W47IQ8X
GUNA MATRIX DETOX	SODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS -	Guna spa	a369b95b-4d57-f149-e053-2995a90a87e3	2020-10-23	Warnings, Adverse reactions	Exact identifier unii: ETJ7Z6XBU4
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	a00c4a93-cde2-4753-81f7-0d6fee9fb690	2020-10-20	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: B22547B95K
Supreme	ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA	BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE	72c4679b-aa97-4888-9178-581d0f99c0b6	2020-09-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ac0fd44a-3f39-8d7e-e053-2995a90afeec	2020-08-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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