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 28 of 81 · 1,614 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
STERILE WATER	WATER	Henry Schein, Inc.	f4087143-9868-4308-b96c-43657ee8ec28	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	31188cdf-7bc8-4d78-bfaf-c1dc9f851fd4	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Teething-Colic	CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE	Newton Laboratories, Inc.	9db30229-3031-ff10-e053-2995a90aff75	2025-11-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Teething-Colic	CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE	Newton Laboratories, Inc.	9db4790e-28c2-2dce-e053-2a95a90ae792	2025-11-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	d3d29c8f-c326-4097-814a-7f4e08c67068	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	01721071-af03-4894-95c1-10b8bc64b888	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose in Lactated Ringers	DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	190da07e-a616-46e6-b4e5-1c0ba39306e5	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	f6d82772-638c-4584-b9d3-8833669f5963	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Bacteriostatic Water	BACTERIOSTATIC WATER	ProPharma Distribution	42c6938e-f747-ae13-e063-6294a90a59a3	2025-11-04	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Com-Pare2 Dual Yeast Relief Plus Multi-symptom Formula	CANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHUR	TRP Company	42b6b9b9-a673-0bba-e063-6394a90a8866	2025-11-03	Warnings	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	ICU Medical Inc.	d8ee14e9-6733-4813-9f21-2b043a5f7188	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	ICU Medical Inc.	4555b1bf-6d97-4798-a63d-6d34291c85ce	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	ICU Medical Inc.	aab10f03-26ae-4dbc-a481-ef025e48b405	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	ICU Medical Inc.	e3484bc6-ed7f-43ef-9d49-c131a8dff2dd	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	3cfdeee0-ff14-4341-8396-b11c2a037c60	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	5f372b75-d7a4-471e-8ac6-290040fc84b0	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	243fe8fc-996a-4855-8daf-069628e547c4	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	d310d170-5eeb-471b-af1a-0e845001d21d	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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