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 | 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#
DailyMed Package Descriptions#
| 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 | 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CONSTIPATION CP | ALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE. | Natural Creations, Inc. | 961b3ddf-41fe-46ed-b5e4-0fd8d9652edf | 2021-11-15 | Warnings | ETJ7Z6XBU4 451W47IQ8X |
| CENTROCODE | AMERICAN GINSENG, ADENOSINE TRIPHOSPHATE, CORTICOTROPIN, ALFALFA, BOS TAURUS HYPOTHALAMUS, PHYTOLACCA AMERICANA ROOT, BOS TAURUS PITUITARY GLAND POSTERIOR, THYROID UNSPECIFIED, IODINE, SILICON DIOXIDE, OSTER SHELL CALCIUM CARBONATE CRUDE, STRYCHNOS IGNATII SEED, IRIDIUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SELENIUM, URANYL NITRATE HEXAHYDRATE. | Natural Creations, Inc. | e5bbe9ec-7602-4de5-907a-7047c10198b6 | 2021-11-15 | Warnings | ETJ7Z6XBU4 451W47IQ8X |
| OHM-ANX | ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, MOSCHUS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, STANNUM METALLICUM, VALERIANA OFFICINALIS | OHM PHARMA INC. | f743b690-8f79-4e60-81cd-e3e2825a1ec8 | 2021-11-15 | Warnings | 451W47IQ8X |
| Hydrate 2 | BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA | Natural Creations, Inc | 52cb98dc-6858-42bf-9c54-d20fb607dfbb | 2021-11-12 | Warnings | ETJ7Z6XBU4 451W47IQ8X |
| Adrenal and DHEA | ARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA. | ProBLEN | 44991952-c440-4a33-9423-a9369c8bab70 | 2021-10-22 | Warnings | 451W47IQ8X |
| Dr. Talbots Daily Allergy Relief | ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC. | 91c2795d-4cde-6e2c-e053-2995a90a0096 | 2021-10-05 | Warnings | 451W47IQ8X |
| Solucion InterSol | SOLUCION ADITIVA PARA PLAQUETAS 3 | Fenwal, Inc. | d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1 | 2021-10-04 | Warnings, Adverse reactions | 451W47IQ8X B22547B95K |
| NATRUM MURIATICUM | NATRUM MURIATICUM | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 520edb18-5f2a-4448-ba53-83408a839e1f | 2021-09-02 | Warnings | 451W47IQ8X |
| SILICEA | SILICEA | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 0000025c-6dbf-4af7-a741-5cbacaed519a | 2021-09-02 | Warnings | ETJ7Z6XBU4 |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Lactated Ringers Irrigation | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE | B. Braun Medical Inc. | 0db56c7a-2b8f-4593-8591-2c481c92b2cf | 2021-08-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride for Irrigation | SODIUM CHLORIDE FOR IRRIGATION | B. Braun Medical Inc. | 5bd9b176-0402-4a3f-a6b4-c3f393fc092a | 2021-08-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| HLU PNEUMO DROPS | ARSENICUM IODATUM, CALCAREA PHOSPHORICA, CARBO VEGETABILIS, ORYCTOLAGUS CUNICULUS LUNG, PHELLANDRIUM AQUATICUM, SILICEA, STANNUM METALLICUM, SULPHUR, THYMUS VULGARIS | Seroyal USA | 2f0acce5-aad5-1dd3-e054-00144ff88e88 | 2021-07-22 | Warnings | ETJ7Z6XBU4 |
| 0.9% SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c755e41b-acba-7234-e053-2995a90aff0f | 2021-07-17 | Warnings, Adverse reactions | 451W47IQ8X |
| Sleep Aid | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH) | Pro Weight Loss Inc. | d0af311a-e975-4236-8c0e-0418efa7e45f | 2021-07-16 | Warnings | ETJ7Z6XBU4 |
| SILICEA 6X | SILICEA | Seroyal USA | 156cb778-c6a8-0681-e054-00144ff8d46c | 2021-07-14 | Warnings | ETJ7Z6XBU4 |
| Melange combination | CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA | Seroyal USA | 0a071fbf-0075-4479-e054-00144ff8d46c | 2021-07-14 | Warnings | ETJ7Z6XBU4 451W47IQ8X |
| 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. | c67b3a39-ef78-5e81-e053-2a95a90a4786 | 2021-07-06 | Warnings | ETJ7Z6XBU4 |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.