Home NDC 68982-261 Balfaxar
Product NDC 68982-261
11-digit product format 689820261
Labeler code 68982
Product ID 68982-261_5be10bd2-a785-7f3b-0d28-d066cd5f7d24
Type PLASMA DERIVATIVE
Nonproprietary name Prothrombin Complex Concentrate (Human)
Dosage form POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Octapharma USA Inc
Application BLA125776
Marketing category BLA
Marketing start 2023-11-30
Substance COAGULATION FACTOR IX HUMAN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN; PROTHROMBIN
Active strength 25.5; 16.5; 24; 22; 22; 26 [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL
Pharmacologic classes Anti-coagulant [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Decreased Coagulation Factor Activity [PE], Enzyme Precursors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Protein C [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Balfaxar
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COAGULATION FACTOR IX HUMAN 25.5 [iU]/mL COAGULATION FACTOR VII HUMAN 16.5 [iU]/mL COAGULATION FACTOR X HUMAN 24 [iU]/mL PROTEIN C 22 [iU]/mL PROTEIN S HUMAN 22 [iU]/mL PROTHROMBIN 26 [iU]/mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68982-261-01 Balfaxar 1 in 1 CARTON POWDER, FOR SOLUTION 1 4 68982-261-02 Balfaxar 1 in 1 CARTON POWDER, FOR SOLUTION 1 4 68982-261-81 Balfaxar 20 mL in 1 VIAL, GLASS POWDER, FOR SOLUTION 20 4 68982-261-82 Balfaxar 40 mL in 1 VIAL, GLASS POWDER, FOR SOLUTION 40 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68982-261 BALFAXAR (PROTHROMBIN COMPLEX CONCENTRATE (HUMAN)) POWDER, FOR SOLUTION [OCTAPHARMA USA INC] 4 Current NDC, 4 package rows 20231130_68fa4f90-8b01-6498-4140-e0be5247c3fe.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2643209 Balfaxar 1 UNT Injection PSN 68fa4f90-8b01-6498-4140-e0be5247c3fe 4 2643204 prothrombin complex concentrate, human-lans 1 UNT Injection PSN 68fa4f90-8b01-6498-4140-e0be5247c3fe 4 2643209 coagulation factor IX, human-lans 1 UNT / coagulation factor X, human-lans 1 UNT / factor VII, human-lans 1 UNT / protein C, human-lans 1 UNT / protein S, human-lans 1 UNT / prothrombin, human-lans 1 UNT Injection [Balfaxar] SBD 68fa4f90-8b01-6498-4140-e0be5247c3fe 4 2643204 coagulation factor IX, human-lans 1 UNT / coagulation factor X, human-lans 1 UNT / factor VII, human-lans 1 UNT / protein C, human-lans 1 UNT / protein S, human-lans 1 UNT / prothrombin, human-lans 1 UNT Injection SCD 68fa4f90-8b01-6498-4140-e0be5247c3fe 4 2643209 Balfaxar 1 UNT Injection SY 68fa4f90-8b01-6498-4140-e0be5247c3fe 4 2643204 prothrombin complex concentrate, human-lans 1 UNT Injection SY 68fa4f90-8b01-6498-4140-e0be5247c3fe 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68982-261-01 68982026101 1 VIAL, GLASS in 1 CARTON (68982-261-01) / 20 mL in 1 VIAL, GLASS (68982-261-81) 2023-11-30 No No Current 68982-261-02 68982026102 1 VIAL, GLASS in 1 CARTON (68982-261-02) / 40 mL in 1 VIAL, GLASS (68982-261-82) 2023-11-30 No No Current 68982-261-81 68982026181 20 mL in 1 VIAL, GLASS 20 ml Historical 68982-261-82 68982026182 40 mL in 1 VIAL, GLASS 40 ml Historical