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 |
|---|---|---|---|---|---|---|
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | 97001218-086c-430a-9e0d-6c7031c91d94 | 2024-05-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | fe5b5182-c859-4c74-b2e0-467be5b2e329 | 2024-05-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | f2475fa3-ab1d-4b81-8127-b58cd0790a54 | 2024-05-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Weed Grass Antigens | ALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS, | Energique, Inc. | 8a28f56a-6010-42e3-b360-e6e22b86222a | 2024-05-02 | Warnings | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | c2467d57-cd2d-4409-bcc0-50128bd01bba | 2024-04-30 | Warnings, Adverse reactions | 451W47IQ8X |
| REFL HS | ADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI) | Deseret Biologicals, Inc. | 83249aee-f58b-442d-9187-6de0cf070e4d | 2024-04-29 | Warnings | QTT17582CB |
| Mineffect eye drops | ALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM | Kadesh Incoporation Co,Ltd | e2259f58-3043-4af3-918d-d4403757aa1f | 2024-04-26 | Warnings | 451W47IQ8X |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Fresenius Kabi USA, LLC | 7a723a23-3bc1-4f69-b82f-d06a35dc68d6 | 2024-04-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | c1e52670-c85e-4f19-a2e9-bf9abd7c3727 | 2024-04-23 | Warnings, Adverse reactions | 451W47IQ8X |
| PEMF Optimizer | AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 97d57469-4c5b-4d3f-9398-3a1a6617a649 | 2024-04-23 | Warnings | 059QF0KO0R |
| Dermapar | EPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUM | Energique, Inc. | f79fe29b-341e-4bee-9665-1805a7157d1a | 2024-04-22 | Warnings | 451W47IQ8X |
| EVTOX | COCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE | BioActive Nutritional, Inc. | 4b518e10-9ce0-492b-92be-6025d8d7c3c6 | 2024-04-19 | Warnings | QTT17582CB |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Hikma Pharmaceuticals USA Inc. | e5ee8caa-b6ca-45ba-98fb-8305e6282141 | 2024-04-10 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Hers Plus | CALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALIS | Deseret Biologicals,Inc. | e4636b80-f6c8-459c-8d0e-ff7801358b10 | 2024-04-09 | Warnings | 451W47IQ8X |
| Dextrose And Sodium Chloride | DEXTROSE AND SODIUM CHLORIDE | B. Braun Medical Inc. | 8e6569ce-9714-497f-a94b-c6975c1d76f6 | 2024-04-02 | Warnings, Adverse reactions | 451W47IQ8X |
| SINU HC | PLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUM | Deseret Biologicals, Inc. | 8b63e066-dd1b-4aee-a17b-4edc6b71a1cc | 2024-04-02 | Warnings | 451W47IQ8X |
| Eye Wash | WATER | M-star (Hubei) Health&Care Products Co., Ltd. | 71706039-e250-4f08-9687-71b2928c4e46 | 2024-04-01 | Warnings | 059QF0KO0R |
| Oral Health | ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS, | Deseret Biologicals, Inc. | 6f66ff40-6e0e-4a35-963c-965c65df76eb | 2024-04-01 | Warnings | QTT17582CB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.