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 | Asclemed USA, Inc. | a411c118-ef0e-4c42-9924-4a06ec690e94 | 2021-01-14 | Adverse reactions | 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. | 997474d5-4dc4-6104-e053-2995a90a03f1 | 2020-12-07 | Warnings | ETJ7Z6XBU4 |
| Intestia | ECHINACEA, IRIS VERSICOLOR, URTICA URENS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, DIOSCOREA VILLOSA, I ODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RHUS TOXICODENDRON, PYROGENIUM | Newton Laboratories, Inc. | 9a132c99-7278-f667-e053-2a95a90a3d2b | 2020-12-04 | Warnings | 451W47IQ8X |
| Multi-System | ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, ECHINACEA, IODIUM, KALI CARBONICUM, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, CANDIDA ALBICANS, THYROIDINUM, USTILAGO MAIDIS, ASPERGILLUS NIGER, CLADOSPORIUM | Newton Laboratories, Inc. | 9a65b40b-873b-346a-e053-2995a90aa968 | 2020-12-04 | Warnings | 451W47IQ8X |
| Oral Care-Gingivitis | ACONITUM NAP., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CALENDULA, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM, HEPAR SULPH. CALC., KREOSOTUM, MERC. VIV., MYRRHA, NUX VOM., PHOSPHORUS, PHYTOLACCA, PLANTAGO, RHUS TOXICODENDRON, SILICEA, STAPHYSAG., ECHINACEA | Newton Laboratories, Inc. | 9971a7f4-c02c-02ba-e053-2a95a90a2b73 | 2020-12-04 | Warnings | ETJ7Z6XBU4 |
| Exhaustion | 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. | 98fc56b6-afed-2cfd-e053-2995a90a59ae | 2020-12-03 | Warnings | 451W47IQ8X |
| Fear | ACONITUM NAP., ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOSPHORUS, SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANA | Newton Laboratories, Inc. | 99485faf-aee1-6482-e053-2a95a90a498b | 2020-12-03 | Warnings | 451W47IQ8X |
| Female Femroids | HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ARSENICUM ALBUM, CALCAREA IODATA, CARBO ANIMALIS, CONIUM MACULATUM, GRAPHITES, HYDRASTIS CANADENSIS, IODIUM, KREOSOTUM, LACHESIS MUTUS, PHOSPHORUS, SABINA, SECALE CORNUTUM, SEPIA, SILICEA, THLASPI BURSA-PASTORIS, THUJA OCCIDENTALIS, THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS. | Newton Laboratories, Inc. | 9a01acb9-1b2b-3a33-e053-2995a90adc92 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9a61f1ae-d3a4-68d7-e053-2a95a90a4333 | 2020-12-03 | Warnings | 451W47IQ8X |
| Fungal | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 99487f4a-76f6-407b-e053-2a95a90acfd4 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b59731a2-c775-7e8a-e053-2a95a90a9062 | 2020-12-03 | Warnings | ETJ7Z6XBU4 |
| Acne - Cystic Acne | ECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEA | Newton Laboratories, Inc | 92afe017-74c7-16c6-e053-2995a90a5c7d | 2020-12-02 | Warnings | ETJ7Z6XBU4 |
| Breast Care - Fibrocystic | 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. | 98d01128-9887-12ce-e053-2a95a90a7329 | 2020-12-02 | Warnings | ETJ7Z6XBU4 |
| Connec-T | ECHINACEA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, CALCAREA FLUORICA, CAPSICUM ANNUUM, CARDUUS MARIANUS, CINCHONA OFFICINALIS, IODIUM, KALI CARBONICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MERCURIUS VIVUS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, SECALE CORNUTUM, THYMUS SERPYLLUM, THUJA OCCIDENTALIS, THYROIDINUM, VERBASCUM THAPSUS. | Newton Laboratories, Inc. | 9a630923-1497-1fc8-e053-2995a90ad001 | 2020-12-02 | Warnings | 451W47IQ8X |
| Distress-Mood-Sadness | 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. | 98d0be75-9b50-1e15-e053-2995a90abf3b | 2020-12-02 | Warnings | 451W47IQ8X |
| Distress-Mood-Sadness | 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. | 98d08917-2f1b-4dc7-e053-2a95a90a1ce0 | 2020-12-02 | Warnings | 451W47IQ8X |
| Thyroid-Adrenal | ADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEA | Newton Laboratories, Inc. | b56f2ffc-4637-1f23-e053-2a95a90aa3af | 2020-12-01 | Warnings | ETJ7Z6XBU4 |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9aefc830-329c-5e35-e053-2a95a90a6ffe | 2020-11-30 | Warnings | 451W47IQ8X |
| Food Additives | IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA, | Newton Laboratories, Inc. | 9af2d6f4-baa8-5da9-e053-2995a90a3dac | 2020-11-30 | Warnings | 451W47IQ8X |
| Hair-Scalp | APIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC. | Newton Laboratories, Inc. | 9ab3b944-443c-74a1-e053-2a95a90aa0e5 | 2020-11-30 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.