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 |
|---|---|---|---|---|---|---|
| F27 MVON | AGRIMONY, ARNICA MONTANA, ARSENICUM ALBUM, ARTEMISIA TRIDENTATA, ASPEN, CHAMOMILE, CHICORY, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, EUCALYPTUS GLOBULUS, HARDY FUCHSIA, HORSE CHESTNUT, IGNATIA AMARA, JUGLANS REGIA, LACHESIS MUTUS, LARIX DECIDUA, MIMULUS GUTTATUS, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, PALLADIUM, PERFOLIATE HONEYSUCKLE, PETUNIA AXILLARIS, PULSATILLA VULGARIS, PYRENEES STAR OF BETHLEHEM, SCOTCH BROOM, TRILLIUM CHLOROPETALUM, YELLOW JASMINE, YERBA SANTA, ZINNIA ELEGANS | Apex Energetics Inc. | bca69508-0934-ecfc-e053-2995a90a0ce3 | 2024-01-08 | Warnings | 451W47IQ8X |
| F26 PRSVR | ALLIUM CEPA WHOLE, APIS MELLIFICA, AURUM METALLICUM, BORAGE, BROMUS RAMOSUS, CALIFORNIA WILDROSE WHOLE, ENGLISH ELM ING TWIG, ENGLISH HAWTHRON, ENGLISH OAK, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, GORSE, LARIX DECIDUA, LUFFA OPERCULATA, MERCURIUS SOLUBILIS, MULLEIN, NATRUM MURIATICUM, PENSTEMON DAVIDSONII WHOLE, PLATINUM METALLICUM, PULSATILLA VULGARIS, PURPLE LOOSESTRIFE WHOLE, ROSA CHINENSIS, SCOTCH BROOM, SEPIA, WILD MUSTARD, YERBA SANTA, ZINCUM METALLICUM | Apex Energetics Inc. | beaef254-bf57-df92-e053-2995a90abd65 | 2024-01-08 | Warnings | 451W47IQ8X |
| G05 OXI-MET | ADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHUR | Apex Energetics Inc. | beb18213-911a-38d4-e053-2a95a90ac17c | 2024-01-08 | Warnings | 451W47IQ8X |
| LIVER PLUS Formula | ADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHUR | Apex Energetics Inc. | d8c7b349-8718-d8ed-e053-2995a90ae988 | 2024-01-08 | Warnings | 451W47IQ8X |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | b56ef662-fec2-4d94-e053-2995a90aba2b | 2024-01-06 | Warnings | 059QF0KO0R |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 037ac04d-f8f3-4bb8-993a-ac8f7683ff83 | 2024-01-04 | Warnings, Adverse reactions | 451W47IQ8X |
| Leader Eye Wash | PURIFIED WATER | Cardinal Health | 8d3ad11f-1945-f838-e053-2995a90a7aa5 | 2023-12-23 | Warnings | 059QF0KO0R |
| Sinus HP | ARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALIS | Energique, Inc. | 3cdddbe5-e3d2-4629-a045-868e18183f1d | 2023-12-19 | Warnings | 451W47IQ8X |
| BSS | BALANCED SALT SOLUTION | Alcon Laboratories, Inc. | 28488c7b-cf6a-4a03-916f-cc66b3afdc57 | 2023-12-14 | Warnings, Adverse reactions | 451W47IQ8X 1Q73Q2JULR |
| Altachlore Sodium Chloride Hypertonicity | SODIUM CHLORIDE | Altaire Pharmaceuticals Inc. | dc0d94d8-4475-4956-8ded-bdb9496074e4 | 2023-12-09 | Warnings | 451W47IQ8X |
| Eye Wash | WATER | Jiangxi Zhenmei Biological Technology Co.,Ltd | c68795b8-bf68-0d01-e053-2a95a90abebb | 2023-12-04 | Warnings | 059QF0KO0R |
| terrasil Eczema and Psoriasis Severe Outbreak | GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 4d7128fb-57f1-4d0d-a83a-daef40928ecd | 2023-11-30 | Warnings | 451W47IQ8X |
| terragen HG Formula Maximum Strength | GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | e632c831-e25d-4d04-ba72-2327d25713b1 | 2023-11-30 | Warnings | 451W47IQ8X |
| Femstat C | ECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIA | Energique, Inc. | 420119ca-f2bf-40e3-9e40-00498724c228 | 2023-11-30 | Warnings | 451W47IQ8X |
| Endopar | GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS) | Energique, Inc. | 06375c3e-cc05-4450-9117-1d3dc72636eb | 2023-11-21 | Warnings | 451W47IQ8X |
| Muriaticum acidum | HYDROCHLORIC ACID | Boiron | 8643994f-4e13-4572-e053-2991aa0a5b78 | 2023-11-14 | QTT17582CB | |
| Muriaticum acidum | HYDROCHLORIC ACID | Boiron | 6907bbfe-caa5-2ce4-e053-2991aa0ade8d | 2023-11-14 | QTT17582CB | |
| Muriaticum acidum | HYDROCHLORIC ACID | Boiron | 8643c518-13b2-658a-e053-2a91aa0ac5ed | 2023-11-14 | QTT17582CB | |
| Muriaticum acidum | HYDROCHLORIC ACID | Boiron | 8643e30e-1f47-09f1-e053-2991aa0ac2de | 2023-11-14 | QTT17582CB | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8646d7ea-cf5e-607d-e053-2a91aa0aeca1 | 2023-11-14 | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.