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 table
LabelManufacturerEffective dateType
Kcentra - CSL Behring GmbH | CSL Behring LLCCSL Behring GmbH | CSL Behring LLC2023-05-16PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63833-397-01Kcentra40 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,40 mL920 U in 40mL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63833-397KCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]13Unmatched20230517_eee1afb8-324c-42e4-8bf0-f0c9da5e6d42.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAGULATION FACTOR IX HUMANACTIVE INGREDIENT6U90Y1795TKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
COAGULATION FACTOR VII HUMANACTIVE INGREDIENT4156XVB4QDKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
COAGULATION FACTOR X HUMANACTIVE INGREDIENT0P94UQE6SYKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Protein CACTIVE INGREDIENT3Z6S89TXPWKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Protein S HumanACTIVE INGREDIENT90J3F6N5FNKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
PROTHROMBINACTIVE INGREDIENT8FB1K07F16KCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
COAGULATION FACTOR IX HUMANACTIVE MOIETY6U90Y1795TKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
COAGULATION FACTOR VII HUMANACTIVE MOIETY4156XVB4QDKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
COAGULATION FACTOR X HUMANACTIVE MOIETY0P94UQE6SYKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Protein CACTIVE MOIETY3Z6S89TXPWKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Protein S HumanACTIVE MOIETY90J3F6N5FNKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
PROTHROMBINACTIVE MOIETY8FB1K07F16KCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
ALBUMIN (HUMAN)INACTIVE INGREDIENTZIF514RVZRKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Antithrombin III (Human)INACTIVE INGREDIENTT0LTO7L82XKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
HeparinINACTIVE INGREDIENTT2410KM04AKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Sodium citrateINACTIVE INGREDIENT1Q73Q2JULRKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IKCENTRA (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND WATER) KIT [CSL BEHRING GMBH]6

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.

Matched openFDA labels page 17 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCce0c8c6f-734a-400f-9b60-a3b1e263f25f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
unii: 451W47IQ8X
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: 451W47IQ8X
BLISTER HPJUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG.Natural Creations, Inc.e76f05e7-6d7b-4d2e-ba26-bf776bf0e6572025-11-13WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPARSENIC TRIOXIDE, CALCIUM CARBONATE, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLANatural Creations, Inc.13d92246-c20e-47a8-b88f-22da876fc5452025-11-13WarningsExact identifier
unii: 451W47IQ8X
ANXIETY II HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.02fa45a5-08e1-41ad-acd4-0f85db07e89e2025-11-13WarningsExact identifier
unii: 451W47IQ8X
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.af6aebad-ef03-4d19-9a40-18e5a278b8122025-11-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.