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 |
|---|---|---|---|---|---|---|
| Hay Fever | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS | Newton Laboratories, Inc. | a6045b91-d361-2731-e053-2a95a90a9772 | 2020-05-18 | Warnings | 451W47IQ8X |
| Isolyte S | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 2020-05-14 | Warnings, Adverse reactions | 451W47IQ8X |
| DEXTROSE AND SODIUM CHLORIDE | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE | Fresenius Kabi USA, LLC | b825c9c4-f2fb-4a4a-9d8c-fb020ad07e93 | 2020-04-30 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2b8220f-e33a-51c3-e053-2995a90a0734 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2bba76a-08ce-6902-e053-2995a90ab9c9 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Electrolyte No. 48 | SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Company | b283a454-0c20-4fbf-92d3-dae1f3cd3cad | 2020-02-13 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | fbc01464-8885-4075-af41-911ffec5ae92 | 2020-01-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Plasma-Lyte A | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | 6ec9e61c-2c26-402f-8604-f446b2e34058 | 2019-08-05 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Dextrose and Sodium Chloride | POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Baxter Healthcare Company | c553fed1-3de5-4826-8eff-633b5923bf0b | 2019-02-21 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | POTASSIUM CHLORIDE AND SODIUM CHLORIDE | Baxter Healthcare Company | becc7410-0a25-49f5-b0c3-240078479dc8 | 2019-01-11 | Warnings, Adverse reactions | 451W47IQ8X |
| Skin Klear Acne Relief | TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR | Homeocare Laboratories | 65afbc20-611b-4bc4-a151-c633bec66a82 | 2018-12-31 | Warnings | 451W47IQ8X |
| H.M.D. | ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM | Zorex International | 8c53091a-904d-4756-93e4-17143c5b48e9 | 2018-12-21 | Warnings | 451W47IQ8X |
| Vitality Female | ARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA | Natural Creations, Inc | 679ba86d-bf84-4ded-b0bf-d55a0df9faa4 | 2018-12-21 | Warnings | 451W47IQ8X |
| Hydrate II | BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA | Zorex International | e5f53495-3b75-4d7c-89af-23058fb6fd05 | 2018-12-21 | Warnings | 451W47IQ8X |
| Dynamic Eyewash with Eyecup | WATER | Dynamic Safety International | 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 | 2018-12-17 | Warnings | 059QF0KO0R |
| WinCo Foods Saline Nasal Relief | SODIUM CHLORIDE | WinCo Foods, LLC | 1280fee4-e763-49ba-8722-8cdb8157f1a4 | 2018-08-02 | Warnings | 451W47IQ8X |
| Bio Rock Water | ROCK WATER | BioActive Nutritional, Inc. | 178bd16d-0d4f-49d8-866b-8ab3a3c6889d | 2018-07-30 | Warnings | 059QF0KO0R |
| Additox | TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | BioActive Nutritional, Inc. | 319ee2fe-58e3-495e-bf0d-df201f6fbb1c | 2018-07-18 | Warnings | 1Q73Q2JULR |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 05dee566-7b82-4216-8a6b-765d2b4d9dc7 | 2018-07-17 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.