NDC 0053-8135

Helixate FS

Antihemophilic Factor, Recombinant

Helixate FS is a Kit in the Plasma Derivative category. It is labeled and distributed by Csl Behring Llc. The primary component is .

Product ID0053-8135_a8999296-44d4-427a-a82d-d23a0c622e71
NDC0053-8135
Product TypePlasma Derivative
Proprietary NameHelixate FS
Generic NameAntihemophilic Factor, Recombinant
Dosage FormKit
Marketing Start Date2009-07-31
Marketing CategoryBLA / BLA
Application NumberBLA103332
Labeler NameCSL Behring LLC
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0053-8135-02

1 KIT in 1 BOX (0053-8135-02) * 5 mL in 1 VIAL, SINGLE-USE (0053-8145-01) * 5 mL in 1 VIAL (0053-7653-07)
Marketing Start Date2009-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0053-8135-02 [00053813502]

HELIXATE FS KIT
Marketing CategoryBLA
Application NumberBLA103332
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2009-07-31

Drug Details

NDC Crossover Matching brand name "Helixate FS" or generic name "Antihemophilic Factor, Recombinant"

NDCBrand NameGeneric Name
0053-8131Helixate FSAntihemophilic Factor, Recombinant
0053-8132Helixate FSAntihemophilic Factor, Recombinant
0053-8133Helixate FSAntihemophilic Factor, Recombinant
0053-8134Helixate FSAntihemophilic Factor, Recombinant
0053-8135Helixate FSAntihemophilic Factor, Recombinant

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.