NDC 63833-397 - Kcentra
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
- 63833-397
- Package NDCs from labels
- 63833-397-01
- Manufacturer
- CSL Behring GmbH | CSL Behring LLC
- Effective date
- 2023-05-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Kcentra - CSL Behring GmbH | CSL Behring LLC | CSL Behring GmbH | CSL Behring LLC | 2023-05-16 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63833-397-01 | Kcentra | 40 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 40 mL | 920 U in 40mL | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63833-397 | KCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH] | 13 | Unmatched | 20230517_eee1afb8-324c-42e4-8bf0-f0c9da5e6d42.zip |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| AllergiClear-M | ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA | Silver Star Brands | 9d36096b-022f-5cfa-e053-2995a90a381f | 2025-01-01 | Warnings | 451W47IQ8X |
| Stress Away Anxiety Relief | ACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUM | Silver Star Brands | 05e04129-e7c1-4e11-e063-6394a90a09ca | 2025-01-01 | Warnings | QTT17582CB |
| DG Health Sterile Saline Mist | SODIUM CHLORIDE | DG Health | f2e44ab4-ae0f-c87b-e053-2a95a90acd04 | 2024-12-31 | Warnings | 451W47IQ8X |
| ALBUMINEX | ALBUMIN HUMAN | BPL | 8428d373-f4b1-4e3b-bb19-ea89048f7c79 | 2024-12-31 | Warnings, Adverse reactions | ZIF514RVZR |
| ALBUMINEX | ALBUMIN HUMAN | BPL | 167f48d0-8ae5-4f7e-b050-9673dad78acc | 2024-12-31 | Warnings, Adverse reactions | ZIF514RVZR |
| Gut Brain Spectrum | ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM | Energique, Inc. | adfee6ce-05b0-4955-bf5f-9612b8db4c78 | 2024-12-26 | Warnings | 451W47IQ8X |
| TREE ANTIGEN | POPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLE | Natural Creations, Inc | 8040ab36-90eb-4076-a478-9b82ccfa4ec9 | 2024-12-23 | Warnings | 451W47IQ8X |
| Sterile Hypertonic Saline Solution 7 Sodium Chloride | SODIUM CHLORIDE | JOONEM LLC | e7110525-9f9b-5b68-e053-2995a90ac034 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | 49309411-9af4-4f19-a3bf-dbeabc106827 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | ba0868f6-d3de-40e2-bcb3-144fa53062c7 | 2024-12-23 | Warnings | 451W47IQ8X |
| Base Laboratories Saline | SODIUM CHLORIDE | Joonem LLC | 9d83f477-ebbc-4248-8445-769178181d4f | 2024-12-23 | Warnings | 451W47IQ8X |
| Trace Mineral Cord | ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM, | Energique, Inc. | 902dd68d-5ce1-481e-8938-6487dcc68dfc | 2024-12-19 | Warnings | 451W47IQ8X |
| Ancient Secrets Breathe Again | SODIUM CHLORIDE | LOTUS BRANDS, INC. | c6d2bab0-d363-4c09-a71b-ae15db915b37 | 2024-12-18 | Warnings | 451W47IQ8X |
| Walgreens Saline Mist Extra Strength | SODIUM CHLORIDE | Walgreen's Corporation | 90cbe2dc-36b6-77fb-e053-2995a90a2897 | 2024-12-18 | Warnings | 451W47IQ8X |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 6f1fe980-ca09-401d-aed6-d3d3387cc49a | 2024-12-18 | Warnings | 451W47IQ8X |
| Mast Cell Pro | HYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM, | Energique, Inc. | 5cd31e1d-0312-48d1-9ecd-d01c6fe3b672 | 2024-12-11 | Warnings | 451W47IQ8X |
| Fendall Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | afda6fc3-7615-b0be-e053-2995a90a6208 | 2024-12-10 | Warnings | 059QF0KO0R |
| Junior Moves | ANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB MET | Silver Star Brands | 822d5481-7854-3fe7-e053-2a91aa0abf55 | 2024-12-03 | Warnings | 451W47IQ8X |
| Stress Away Anxiety Relief | ACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUM | Silver Star Brands | 9d75666e-3214-2bab-e053-2a95a90af719 | 2024-12-03 | Warnings | QTT17582CB |
| Migo-Ease | ACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLA | Silver Star Brands | 816837f5-4487-657d-e053-2991aa0a78f4 | 2024-12-03 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.