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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 4a655cde-283f-4ec8-a3d9-5f539c55c204 | 2021-05-10 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ed8fd0c1-ac42-4267-877e-ceadf3831c90 | 2021-04-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Dr. Talbots Vital 12 | CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC | Talbot's Pharmaceuticals Family Products, LLC | c10bb804-8169-63da-e053-2a95a90a8306 | 2021-04-28 | Warnings | ETJ7Z6XBU4 451W47IQ8X |
| Dr. Talbots Infant 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 | c0963200-67dd-6349-e053-2a95a90adde1 | 2021-04-22 | Warnings | 451W47IQ8X |
| CLINIMIX E | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE | Baxter Healthcare Company | 8469d6fb-d6ef-476f-8cc3-0905192de0a8 | 2021-04-13 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Medical Purchasing Solutions, LLC | c3f8e83c-4fb9-91da-e053-2a95a90abd63 | 2021-04-12 | Adverse reactions | 451W47IQ8X |
| CVS Health Sterile Saline Mist Live Better | SODIUM CHLORIDE | CVS Pharmacy | ccc3ab8c-b22f-420d-869b-f2a65b8c7180 | 2021-03-13 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | aeaed9cb-b629-4019-88d2-a916179427de | 2021-02-19 | Warnings, Adverse reactions | 451W47IQ8X |
| GUNA SINUS PLUS | ALTHAEA OFFICINALIS LEAF - CALCIUM SULFIDE - COPPER - DRIMIA MARITIMA BULB - ECHINACEA ANGUSTIFOLIA - HYDRASTIS CANADENSIS WHOLE - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR WHOLE - POTASSIUM DICHROMATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - | Guna spa | b48c5634-24cf-343e-e053-2995a90a3a9a | 2021-02-17 | Warnings | ETJ7Z6XBU4 |
| GUNA OSTEO | ARNICA MONTANA ROOT - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - EQUISETUM HYEMALE - FUMARIC ACID - SUS SCROFA UMBILICAL CORD - SUS SCROFA OVARY - SUS SCROFA PLACENTA - COMFREY ROOT - SUCCINIC ACID - SILICON DIOXIDE - | Guna spa | ba4462d6-9751-530f-e053-2995a90a1f16 | 2021-02-17 | Warnings | ETJ7Z6XBU4 |
| GUNA KIDNEY PLUS | CALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP - | Guna spa | b8dacd94-8da1-4a8d-e053-2995a90acb67 | 2021-02-04 | Warnings | 451W47IQ8X |
| Natrum Muriaticum | NATRUM MURIATICUM | True Botanica, LLC | b30b2880-28a1-47bd-83e7-da885a7c6f77 | 2021-01-24 | Warnings | 451W47IQ8X |
| Flora Plus | ALOE, ALUMINA, ANTIMON CRUD, ARG NIT, CHELIDONIUM MAJ, GAMBOGIA, GRAPHITES, HYDRASTIS, LYCOPODIUM, SILICEA | NET Remedies | fc1ced48-bd9f-4b3f-b786-573fba072975 | 2021-01-21 | Warnings | ETJ7Z6XBU4 |
| Scars-Adhesions | CALC FLUOR, CAUSTICUM, GRAPHITES, HYDROFLUORICUM AC, LACHESIS, PLUMB MET, RHUS TOX, SEPIA, SILICEA, THIOSINAMINUM | NET Remedies | b6bae38b-90c3-47bc-9d6f-8ce6640bbedc | 2021-01-21 | Warnings | ETJ7Z6XBU4 |
| Met-Tox | ARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODES | wHITE mANUFACTURING INC DBA MICRO-WEST | e65db4c2-0bc7-4c50-8f18-b36ee004c4f5 | 2021-01-21 | Warnings | 451W47IQ8X |
| HPZ | ECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCC | White Manufacturing Inc. DBA Micro-West | dfbb5a35-8dfe-48f4-9177-6cb52fb44090 | 2021-01-21 | Warnings | 451W47IQ8X |
| Day and Night Vitals | ALLIUM SAT, ALOE, ARSENICUM ALB, BERBER VULG, CALC PHOS, CEANOTHUS, CHELIDONIUM MAJ, CHOLESTERINUM, CLEMATIS ERECTA, CONDURANGO, GAMBOGIA, HAMAMELIS, KALI BROM, KALI PHOS, LYCOPODIUM, NAT CARB, PASSIFLORA, SENNA, SILICEA, SOLIDAGO, SPIGELIA ANTH, SPONGIA, VERATRUM VIR | NET Remedies | d5ddba51-5f0c-4b06-8f87-3cd6faf64b79 | 2021-01-19 | Warnings | ETJ7Z6XBU4 |
| Metal | ALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIA | NET Remedies | f7682a4e-c767-4429-98aa-e8c5ef6560a6 | 2021-01-19 | Warnings | ETJ7Z6XBU4 451W47IQ8X |
| 3% Sodium Chloride | 3% SODIUM CHLORIDE | Becton Dickinson and Company | a8058593-48af-457a-b0f0-166935c7d10c | 2021-01-14 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.