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 67 of 78 · 1,548 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nat Mur	SODIUM CHLORIDE	Hyland's Inc.	d3ab4254-daaf-24ac-e053-2995a90afb8f	2022-12-13	Warnings	Exact identifier unii: 451W47IQ8X
Rest	SILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIAN	Hyland's Inc.	5e9924be-4dad-324a-e053-2a91aa0a8ec1	2022-12-13	Warnings	Exact identifier unii: 451W47IQ8X
Defend Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	bb851be1-0528-4199-91e7-e09f994b2862	2022-12-12	Warnings	Exact identifier unii: ETJ7Z6XBU4 unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDE	BACTERIOSTATIC SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7611e508-6da2-3a2f-e053-2a91aa0a9f40	2022-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDE	BACTERIOSTATIC SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	763ff805-af1a-e8e9-e053-2a91aa0a8253	2022-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2fae04e3-20b1-4b8c-b1fb-646b384836f1	2022-12-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
MET TOX	ARSENICUM ALB, AVENA, BERBERIS VULG, LYCOPODIUM, NAT MUR, NUX VOM, PHYTOLACCA, RHAMNUS FRANG, SOLIDAGO, TRIFOLIUM PRAT	White Manufacturing Inc. DBA Micro-West	2653d62b-5dd7-482c-b31c-ce5fa1373900	2022-12-02	Warnings	Exact identifier unii: 451W47IQ8X
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA	OHM PHARMA INC.	044a7174-f7a3-490f-9cad-01f2665d7575	2022-12-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
Miranda Castros Healing Gel for Bites and Stings	CALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS.	OHM PHARMA INC.	8e06aaa4-c177-45cf-9d8d-e0099de25668	2022-12-02	Warnings	Exact identifier unii: 451W47IQ8X
Yonis Bliss	CHAMOMILLA, NATRUM MURIATICUM	Brookhaus Essentials LLC	ea4091d6-d295-41a0-aae5-68f3c260e110	2022-11-30	Warnings	Exact identifier unii: 451W47IQ8X
4 Kids Cold and Mucus Nighttime	EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR	Hyland's Inc.	6f7b2585-2f0e-5938-e053-2a91aa0aa9d1	2022-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4 unii: 451W47IQ8X
4 Kids Complete Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	ef39fe3d-a42d-4baa-9199-91f664feb432	2022-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4 unii: 451W47IQ8X
Multiple Electrolytes pH 7.4	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	84221110-b3f1-42f4-800c-ad1d3b330e9e	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Multiple Electrolytes pH 5.5	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Natrum Muriaticum	NATRUM MURIATICUM	Hahnemann Laboratories, INC.	ecf06f13-012c-212d-e053-2995a90a7198	2022-11-08		Exact identifier unii: 451W47IQ8X
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	ANTICOAGULANT SODIUM CITRATE SOLUTION	Fenwal, Inc.	14b238ab-904b-45dc-9eb9-a1074364e089	2022-11-07		Exact identifier unii: B22547B95K
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION	Fenwal, Inc.	d55cb701-9664-4931-8754-1a8cae68da06	2022-11-01		Exact identifier unii: XF417D3PSL unii: B22547B95K
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTION	Fenwal, Inc.	f9d7f1b4-7a77-44f9-8924-10b16008b49d	2022-11-01		Exact identifier unii: XF417D3PSL unii: B22547B95K
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)	Fenwal, Inc.	4a08a9ec-46a5-4fcf-80ee-5c33f1a8b746	2022-11-01		Exact identifier unii: XF417D3PSL unii: B22547B95K
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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