Home NDC 63833-386 Kcentra
Product NDC 63833-386
11-digit product format 638330386
Labeler code 63833
Product ID 63833-386_bf67ad30-c0b2-456a-beda-f65ee1830c3f
Type PLASMA DERIVATIVE
Nonproprietary name PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, Protein C, Protein S Human, and Water
Dosage form KIT
Labeler CSL Behring GmbH
Application BLA125421
Marketing category BLA
Marketing start 2013-04-29
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Kcentra
Listing expiration 2026-12-31 DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63833-386-02 Kcentra 1 in 1 CARTON KIT 1 13 63833-396-01 Kcentra 20 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 20 mL 460 U in 20mL 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COAGULATION FACTOR IX HUMAN ACTIVE INGREDIENT 6U90Y1795T 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] 6 COAGULATION FACTOR VII HUMAN ACTIVE INGREDIENT 4156XVB4QD 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] 6 COAGULATION FACTOR X HUMAN ACTIVE INGREDIENT 0P94UQE6SY 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] 6 Protein C ACTIVE INGREDIENT 3Z6S89TXPW 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] 6 Protein S Human ACTIVE INGREDIENT 90J3F6N5FN 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] 6 PROTHROMBIN ACTIVE INGREDIENT 8FB1K07F16 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] 6 COAGULATION FACTOR IX HUMAN ACTIVE MOIETY 6U90Y1795T 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] 6 COAGULATION FACTOR VII HUMAN ACTIVE MOIETY 4156XVB4QD 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] 6 COAGULATION FACTOR X HUMAN ACTIVE MOIETY 0P94UQE6SY 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] 6 Protein C ACTIVE MOIETY 3Z6S89TXPW 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] 6 Protein S Human ACTIVE MOIETY 90J3F6N5FN 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] 6 PROTHROMBIN ACTIVE MOIETY 8FB1K07F16 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] 6 ALBUMIN (HUMAN) INACTIVE INGREDIENT ZIF514RVZR 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] 6 Antithrombin III (Human) INACTIVE INGREDIENT T0LTO7L82X 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] 6 Heparin INACTIVE INGREDIENT T2410KM04A 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] 6 Hydrochloric acid INACTIVE INGREDIENT QTT17582CB 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] 6 Sodium chloride INACTIVE INGREDIENT 451W47IQ8X 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] 6 Sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR 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] 6 Sodium hydroxide INACTIVE INGREDIENT 55X04QC32I 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] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63833-386 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 Current NDC, Legacy NDC, 2 package rows 20230517_eee1afb8-324c-42e4-8bf0-f0c9da5e6d42.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1484963 Kcentra 1 UNT Injection PSN eee1afb8-324c-42e4-8bf0-f0c9da5e6d42 13 1484958 prothrombin complex concentrate (human) 1 UNT Injection PSN eee1afb8-324c-42e4-8bf0-f0c9da5e6d42 13 1484963 coagulation factor IX, human 1 UNT / coagulation factor X, human 1 UNT / factor VII, human 1 UNT / protein C, human 1 UNT / protein S, human 1 UNT / prothrombin, human 1 UNT Injection [Kcentra] SBD eee1afb8-324c-42e4-8bf0-f0c9da5e6d42 13 1484958 coagulation factor IX, human 1 UNT / coagulation factor X, human 1 UNT / factor VII, human 1 UNT / protein C, human 1 UNT / protein S, human 1 UNT / prothrombin, human 1 UNT Injection SCD eee1afb8-324c-42e4-8bf0-f0c9da5e6d42 13 1484963 Kcentra 1 UNT Injection SY eee1afb8-324c-42e4-8bf0-f0c9da5e6d42 13 1484958 prothrombin complex concentrate human 1 UNT Injection SY eee1afb8-324c-42e4-8bf0-f0c9da5e6d42 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63833-386-02 63833038602 1 KIT in 1 CARTON (63833-386-02) * 20 mL in 1 VIAL, SINGLE-USE (63833-396-01) * 20 mL in 1 VIAL, SINGLE-USE (63833-761-20) 1 kit 2013-04-29 0000-00-00 No No Current 63833-396-01 63833039601 20 mL in 1 VIAL, SINGLE-USE 20 ml Historical