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 |
|---|---|---|---|---|---|---|
| GAVILYTE G TM | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | Lupin Pharmaceuticals,Inc. | 3978822b-6473-4072-9f80-20ceb9bea355 | 2025-09-10 | Warnings, Adverse reactions | 451W47IQ8X |
| Schuessler Tissue Salts Comb 12 General Tonic | CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA | Martin & Pleasance Pty Ltd | 9083a01b-2fbe-4e04-9eec-bf4f65950ec7 | 2025-09-09 | Warnings | 451W47IQ8X |
| Schuessler Tissue Salts Comb 12 General Tonic | CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA | Martin & Pleasance Pty Ltd | c14c79ab-85bb-45f2-83d1-1d9c298ffdfd | 2025-09-08 | Warnings | 451W47IQ8X |
| Medi-First First Aid Eye Wash | PURIFIED WATER | Unifirst First Aid Corporation | dcd7fe56-ff5c-4c8d-a415-6e363d7e53f4 | 2025-09-08 | Warnings | 059QF0KO0R |
| Green Guard First Aid Eye Wash | WATER | Unifirst First Aid Corporation | a4ba5526-b4e2-4bcc-9127-aa22ebf5017f | 2025-09-08 | Warnings | 059QF0KO0R |
| Medi-First Plus First Aid Eye Wash | WATER | Unifirst First Aid Corporation | d7ea80ca-b4a0-4476-8b50-b3425c6d456a | 2025-09-08 | Warnings | 059QF0KO0R |
| ECOLAB Eye Wash | PURIFIED WATER | ECOLAB Food Safety Specialties, Inc. | 4bcfa21a-791e-4d04-e054-00144ff88e88 | 2025-09-08 | Warnings | 059QF0KO0R |
| Physicians Care Eyewash | EYEWASH | Acme United Corporation | 3e239b12-9a75-339d-e063-6294a90a72ae | 2025-09-06 | Warnings | 059QF0KO0R |
| Polyethylene Glycol 3350 and electrolytes - Unflavored | POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED | Strides Pharma Science Limited | 48c741a9-9039-4fdb-a875-86d4ea968282 | 2025-09-05 | Warnings, Adverse reactions | 451W47IQ8X |
| Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED | Strides Pharma Science Limited | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 2025-09-01 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER INJECTION | Henry Schein, Inc. | 3501952b-b556-4d5e-b81b-5c35ff87b475 | 2025-08-28 | Warnings, Adverse reactions | 059QF0KO0R |
| Dextrose and Sodium Chloride | DEXTROSE AND SODIUM CHLORIDE | Baxter Healthcare Company | dcbf1907-1841-4afc-ab5d-a9893a2d7256 | 2025-08-26 | Warnings, Adverse reactions | 451W47IQ8X |
| terrasil Fast and Natural Wart Removal | GRAPHITE 10X, NATRUM MURIATICUM 3X, SYMPHYTUM OFFICINALE (COMFREY) 1X, THUJA OCCIDENTALIS 3X | Aidance Scientific, Inc. | 3d367c0f-5a28-eded-e063-6394a90ad2dc | 2025-08-25 | Warnings | 451W47IQ8X |
| Cold Sore Treatment Extra Strength | ECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, AND CALENDULA OFFICINALIS FLOWERING TOP | Forces of Nature | 0a5d32dc-c0e7-404e-85f2-6c3a338560ba | 2025-08-22 | Warnings | 451W47IQ8X |
| Incontinence | ALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTIS | Newton Laboratories, Inc. | 994cbc8e-a221-1548-e053-2995a90a1f7f | 2025-08-20 | Warnings | 451W47IQ8X |
| Jacksons Cell Salts NAT MUR 6X 9 | NATRUM MURIATICUM | Zettl Health Inc. | 3cbe47fc-db38-e6e9-e063-6294a90a3f1c | 2025-08-19 | Warnings | 451W47IQ8X |
| QUALITY CHOICE SALINE | SODIUM CHLORIDE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | f51491d8-12ad-4b1b-a171-c621bfdcc341 | 2025-08-12 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | e0466bb3-6c26-4044-b051-69f48b67f632 | 2025-08-07 | Adverse reactions | 451W47IQ8X |
| Schuessler Tissue Salts Nat Mur Fluid Balance 9 | NATRUM MURIATICUM | Martin & Pleasance Pty Ltd | 08da6353-9625-4e8f-8575-a2b49f5d2ac6 | 2025-08-04 | Warnings | 451W47IQ8X |
| Gout Relief 3310-S | CELERY SEED, MEDICAGO SATIVA WHOLE,CHICORY ROOT | Bispit Canada Ltd. | 3afaa7d9-3de3-52d9-e063-6294a90a54ec | 2025-08-02 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.