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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 464c2d78-5c88-4668-a039-56dd3c1c9b20 | 2024-12-03 | 451W47IQ8X | |
| XX Health Pro | LACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHUR | Silver Star Brands | 4d11a65e-696a-0727-e054-00144ff88e88 | 2024-12-02 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d41602-9dcb-eaa8-e063-6394a90a7cfa | 2024-11-26 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d4ddaf-9c07-a7fc-e063-6394a90adc0b | 2024-11-26 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d5997b-1cae-41c2-e063-6394a90ac74a | 2024-11-26 | Warnings | 451W47IQ8X |
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% | PURIFIED WATER 98.3% | Acme United Corporation | 9248ee71-2d47-620d-e053-2995a90af5c8 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | cca454e0-b2bd-4215-bc06-426fcc3f7bd6 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | d3812fa3-9334-464d-b50c-98548ff76727 | 2024-11-26 | Warnings | 059QF0KO0R |
| DANGTTEOL | MINERAL WATER | AQBC CO., LTD | 27db14a9-3812-433f-e063-6394a90a11e7 | 2024-11-26 | Warnings | 059QF0KO0R |
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM | Energetix Corporation | 37063a49-6b45-4167-875d-49c9dac3f79b | 2024-11-20 | Warnings | 451W47IQ8X |
| TRICITRATES | POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE | PAI Holdings, LLC dba PAI Pharma | 2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad | 2024-11-15 | Warnings, Adverse reactions | 1Q73Q2JULR |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Pharmaceutical Associates, Inc. | 63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5 | 2024-11-13 | Adverse reactions | 1Q73Q2JULR |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 99a15716-bbb9-4e33-a48d-20c58b81f392 | 2024-11-13 | 451W47IQ8X | |
| Itch Formula | ANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENS | Deseret Biologicals, Inc. | 4dfb177b-bff3-4b6d-8fd9-cadd1df7812c | 2024-11-12 | Warnings | 451W47IQ8X |
| Plasma-Lyte 148 (pH 7.4) | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | fe935c8d-f42d-42e4-8665-0dc66829f231 | 2024-11-08 | 451W47IQ8X | |
| Crane Safety Eye Wash | WATER SOLUTION | Crane Safety LLC | 96d8dda9-6cd6-3f68-e053-2995a90a0da2 | 2024-11-08 | Warnings | 059QF0KO0R |
| RUGBY EYE WASH | WATER, PURIFIED | A-S Medication Solutions | 0773e558-2f46-494c-888a-3bc517202b65 | 2024-11-08 | Warnings | 059QF0KO0R |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | BECTON DICKINSON AND COMPANY | d3f90d2f-4536-4d32-800b-7a798f8a35db | 2024-11-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Hospira, Inc. | 8eb172da-dcd4-4660-4a8f-ad44a14b4af7 | 2024-11-06 | Adverse reactions | 451W47IQ8X |
| Licefreee Everyday | SODIUM CHLORIDE | Tec Laboratories,Inc. | 407b5fd6-2331-2ba7-e054-00144ff88e88 | 2024-11-05 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.