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 |
|---|---|---|---|---|---|---|
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | ad42a7e3-84ea-390d-e053-2a95a90a3a32 | 2024-06-14 | Warnings | 059QF0KO0R |
| Derma Pain Plus | CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII) | Peaceful Mountain, Inc. | 6fa79c31-e48e-4c83-baa2-96cef22cfee1 | 2024-06-13 | Warnings | 451W47IQ8X |
| Cold Sore Rescue | BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA | Peaceful Mountain, Inc. | a7fe6ec7-a758-43cf-b46f-c327e0632fb8 | 2024-06-13 | Warnings | 451W47IQ8X |
| Eyes Alive Eye Wash | WATER | RIVIERA PHARMA INC | 081079f4-1c06-4054-b771-00fedaa666f6 | 2024-06-05 | Warnings | 059QF0KO0R |
| NATRUM MUR | NATRUM MUR | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 1a22655a-68f3-4f13-e063-6294a90ae52c | 2024-06-05 | Warnings | 451W47IQ8X |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID | Chartwell RX, LLC | 525136c9-7758-437b-b57b-94b905786825 | 2024-05-31 | Adverse reactions | 1Q73Q2JULR |
| Sterile Water | WATER | Becton Dickinson and Company | 6e43c5a3-dad2-49ed-b500-964cb4563cc9 | 2024-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Mentox HP | AURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS | Energique, Inc. | ebb23637-4931-4563-ab30-99bea0276580 | 2024-05-28 | Warnings | 451W47IQ8X |
| Potassium Chloride in Lactated Ringers and Dextrose | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE | Fresenius Kabi USA, LLC | dbed53b7-0109-4561-8342-0178ec8c64b0 | 2024-05-22 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | Fresenius Kabi USA, LLC | 1b912c7e-f005-4af4-b683-083440964249 | 2024-05-22 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 239a5af1-7498-480f-862c-ab7c3d89d183 | 2024-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | ebc8b008-a8b3-4c41-89e4-b413f7aab89f | 2024-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 9d5dea47-5103-21a3-e053-2995a90aee78 | 2024-05-20 | Warnings | 451W47IQ8X |
| Colopar | COLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALIS | Energique, Inc. | c47d7203-abcd-4ae5-bf9b-5df07e07d3c1 | 2024-05-20 | Warnings | 451W47IQ8X |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | 4510fe59-cc28-4585-925f-42508a60abd0 | 2024-05-13 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 47a0313f-36df-4fa6-a828-c9e1946ba9b0 | 2024-05-08 | Warnings, Adverse reactions | 451W47IQ8X |
| Fatigue Stat CM | ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODE | Energique, Inc | aebdb08b-48aa-46f2-930f-f98f5b06a604 | 2024-05-08 | Warnings | QTT17582CB |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | f0cc6713-4d47-49be-8116-901c99002b6b | 2024-05-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 7f22c06b-6b4d-4b49-a4b2-d2169f2bd653 | 2024-05-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | Asclemed USA, Inc. | f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff | 2024-05-07 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.