NDC 68516-3603

AlphaNine SD

Coagulation Factor Ix (human)

AlphaNine SD is a Intravenous Kit in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is .

Product ID68516-3603_3d092e6a-6ace-47a6-84fd-0fcf676a0553
NDC68516-3603
Product TypePlasma Derivative
Proprietary NameAlphaNine SD
Generic NameCoagulation Factor Ix (human)
Dosage FormKit
Route of AdministrationINTRAVENOUS
Marketing Start Date1990-12-31
Marketing CategoryBLA / BLA
Application NumberBLA103249
Labeler NameGRIFOLS USA, LLC
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68516-3603-2

1 KIT in 1 CARTON (68516-3603-2) * 10 mL in 1 VIAL (68516-3606-2) * 10 mL in 1 VIAL, SINGLE-DOSE (63323-185-10)
Marketing Start Date1990-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68516-3603-2 [68516360302]

AlphaNine SD KIT
Marketing CategoryBLA
Application NumberBLA103249
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date1990-12-31
Marketing End Date2019-10-31

Drug Details

NDC Crossover Matching brand name "AlphaNine SD" or generic name "Coagulation Factor Ix (human)"

NDCBrand NameGeneric Name
68516-3601AlphaNineCOAGULATION FACTOR IX (HUMAN)
68516-3602AlphaNineCOAGULATION FACTOR IX (HUMAN)
68516-3603AlphaNineCOAGULATION FACTOR IX (HUMAN)
68516-3607AlphaNineCOAGULATION FACTOR IX (HUMAN)
68516-3608AlphaNineCOAGULATION FACTOR IX (HUMAN)
68516-3609AlphaNineCOAGULATION FACTOR IX (HUMAN)
68516-3610AlphaNineCOAGULATION FACTOR IX (HUMAN)
68516-3611AlphaNineCOAGULATION FACTOR IX (HUMAN)
68516-3612AlphaNineCOAGULATION FACTOR IX (HUMAN)

Trademark Results [AlphaNine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALPHANINE
ALPHANINE
73823391 1623234 Live/Registered
ALPHA THERAPEUTIC CORPORATION
1989-08-31

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