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 |
|---|---|---|---|---|---|---|
| QUALITY CHOICE SALINE | PLUS SOOTHING ALOE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 4ae4e88a-aaa5-4195-bedc-622fd5cd9394 | 2025-07-30 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | 9e72418a-376e-4637-99ad-d13c904a7986 | 2025-07-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 985a3341-0fe0-1dd6-e053-2a95a90ad2c5 | 2025-07-25 | Warnings | 451W47IQ8X |
| Dairy-Grain-Nightshade | IRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE. | Newton Laboratories, Inc. | 99fcbd61-ecc8-cf9d-e053-2995a90aebeb | 2025-07-25 | Warnings | 451W47IQ8X |
| Bedwetting | ECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUS | Newton Laboratories, Inc. | 9d5f51d0-01e9-271c-e053-2995a90a63bc | 2025-07-24 | Warnings | 451W47IQ8X |
| Bedwetting | ECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUS | Newton Laboratories, Inc. | 9d6058a0-69dd-66d0-e053-2a95a90a58f8 | 2025-07-24 | Warnings | 451W47IQ8X |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 7a1b4e96-c96f-6424-e053-2991aa0aef30 | 2025-07-24 | Warnings | 451W47IQ8X |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 7a1a9ef9-9a54-5f94-e053-2a91aa0ab477 | 2025-07-24 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Nextgen Pharmaceuticals LLC | 28f79c75-82d2-4912-81fc-a723b5ccf4c1 | 2025-07-23 | Warnings, Adverse reactions | 451W47IQ8X |
| BACTERIOSTATIC SODIUM CHLORIDE | SODIUM CHLORIDE | ProPharma Distribution | 3868864f-4f46-d2a1-e063-6394a90a65d5 | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| Aller-Chord F | ACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE. | Energetix Corporation | ff4eb7b2-8272-4bd3-99a9-7e589b30d59a | 2025-07-15 | Warnings | 451W47IQ8X |
| Sterile Water | STERILE WATER | Nephron Pharmaceuticals Corporation | bc04a883-babc-87a6-e053-2995a90a3dfd | 2025-07-11 | Warnings, Adverse reactions | 059QF0KO0R |
| HerpaOne | GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 6b196d97-6446-4651-97ef-6615cf3e3173 | 2025-07-11 | Warnings | 451W47IQ8X |
| POTASSIUM CHLORIDE IN SODIUM CHLORIDE | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | B. Braun Medical Inc. | ecc38772-246a-46c4-b42a-b9b81124f27f | 2025-07-11 | Warnings, Adverse reactions | 451W47IQ8X |
| Leader Sinus Wash Saline Refill Packets | SODIUM BICARBONATE, SODIUM CHLORIDE | Cardinal Health, 110 dba LEADER | fb192a6d-318e-4d2b-89b6-42ac023e4fbd | 2025-07-09 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 0d59a04a-32e6-485b-b638-a1e6c09e9642 | 2025-07-09 | Warnings, Adverse reactions | 451W47IQ8X |
| Schuessler Tissue Salts Nat Mur Fluid Balance 9 | NATRUM MURIATICUM | Martin & Pleasance Pty Ltd | 0b21c366-fff6-4754-a671-35481ec2c4bd | 2025-07-07 | Warnings | 451W47IQ8X |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Belleview Biosciences LLC | 3245e0e5-5e7f-c3f7-e063-6394a90ac258 | 2025-07-07 | Adverse reactions | 1Q73Q2JULR |
| Normal Salt | SODIUM CHLORIDE | Twin Med LLC | dc82ff0f-8600-373a-e053-2995a90a7505 | 2025-07-03 | Warnings | 451W47IQ8X |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Advanced Rx LLC | 40f471b7-27cf-4ad4-aef6-cc9d0623ddd9 | 2025-07-02 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.