NDC 63833-396 - 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
- 63833-396
- Package NDCs from labels
- 63833-396-01
- 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 |
|---|---|---|---|---|---|---|
| 63833-396-01 | Kcentra | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 460 U in 20mL | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63833-396 | 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 |
|---|---|---|---|---|---|---|
| D-43 | ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATE | DNA Labs, Inc. | 937e2b7e-4001-402f-bd12-dcff4627e928 | 2025-01-13 | Warnings | 451W47IQ8X |
| D-78 | HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJOR | DNA Labs, Inc. | d62673a9-8a67-4580-a8bf-25f85960a555 | 2025-01-13 | Warnings | 451W47IQ8X |
| D-86 | ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDE | DNA Labs, Inc. | 54fa62d3-c129-4826-a794-f3dcc6b855bf | 2025-01-13 | Warnings | 451W47IQ8X |
| D-98 | STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARK | DNA Labs, Inc. | 9b39b277-9eb2-44c9-9c0c-a8680a50e18d | 2025-01-13 | Warnings | 451W47IQ8X |
| D-129 | SODIUM CHLORIDE | DNA Labs, Inc. | ef130f08-1c34-4774-9298-2d1997e631fc | 2025-01-13 | Warnings | 451W47IQ8X |
| D-50 | HORSE CHESTNUT, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, AND STRONTIUM CARBONATE | DNA Labs, Inc. | df118b9b-dee7-4555-bcae-751007c1fd2c | 2025-01-13 | Warnings | 451W47IQ8X |
| D-68 | CROTON OIL, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, AND TOXICODENDRON PUBESCENS LEAF | DNA Labs, Inc. | 01ae098b-aadd-4edc-bf73-6bc60903e779 | 2025-01-13 | Warnings | 451W47IQ8X |
| D-53 | AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTA | DNA Labs, Inc. | 3787d569-ee4d-41de-9519-73c11b626b38 | 2025-01-13 | Warnings | 451W47IQ8X |
| D-51 | ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATE | DNA Labs, Inc. | 9928dd54-bd3a-47cb-bde5-4bebab3db683 | 2025-01-13 | Warnings | 451W47IQ8X |
| D-112 | LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | DNA Labs, Inc. | 8d517ef2-3a1e-4393-9452-a4cd0f0a3bca | 2025-01-13 | Warnings | 451W47IQ8X |
| D-114 | ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACID | DNA Labs | f6f7d369-64ef-0ed9-e053-6294a90a40fa | 2025-01-13 | Warnings | QTT17582CB |
| D-65 | ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDE | DNA Labs, Inc. | 94d4b66a-f995-4516-bdcf-2152c2a624dd | 2025-01-13 | Warnings | 451W47IQ8X |
| D-88 | COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIAN | DNA Labs, Inc. | 1eefff9c-d86c-44ef-b968-9a8c5a9c5403 | 2025-01-13 | Warnings | 451W47IQ8X |
| D-133 | CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATE | DNA Labs, Inc. | a250b7e9-7fd2-4cb0-82f3-baa089d17441 | 2025-01-13 | Warnings | 451W47IQ8X |
| Premixed saline packets | SODIUM CHLORIDE, SODIUM BICARBONATE | Shenzhen Kerui lntl Trading Co., Ltd | 0d11e07b-c137-6efc-e063-6394a90a6bba | 2025-01-09 | Warnings | 451W47IQ8X |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | AvPAK | fe070e2e-3e72-fb84-e053-6294a90afd88 | 2025-01-09 | Adverse reactions | 1Q73Q2JULR |
| STERILE WATER | STERILE WATER | HF Acquisition Co. LLC, DBA HealthFirst | 74ed2a6f-824c-a1ff-e053-2a91aa0a57c0 | 2025-01-09 | Warnings, Adverse reactions | 059QF0KO0R |
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b83 | 2025-01-09 | Warnings, Adverse reactions | 059QF0KO0R |
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 7610bf80-61b7-982f-e053-2a91aa0ac1bb | 2025-01-09 | Warnings, Adverse reactions | 059QF0KO0R |
| A-36 | BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAF | DNA Labs, Inc. | 161c4738-9ead-4687-9f5a-029d5a496e07 | 2025-01-09 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.