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 ID: 68516-3603_3d092e6a-6ace-47a6-84fd-0fcf676a0553
• NDC: 68516-3603
• Product Type: Plasma Derivative
• Proprietary Name: AlphaNine SD
• Generic Name: Coagulation Factor Ix (human)
• Dosage Form: Kit
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1990-12-31
• Marketing Category: BLA / BLA
• Application Number: BLA103249
• Labeler Name: GRIFOLS USA, LLC
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 1990-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68516-3603-2 [68516360302]

AlphaNine SD KIT

• Marketing Category: BLA
• Application Number: BLA103249
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 1990-12-31
• Marketing End Date: 2019-10-31

Drug Details

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

NDC	Brand Name	Generic Name
68516-3601	AlphaNine	COAGULATION FACTOR IX (HUMAN)
68516-3602	AlphaNine	COAGULATION FACTOR IX (HUMAN)
68516-3603	AlphaNine	COAGULATION FACTOR IX (HUMAN)
68516-3607	AlphaNine	COAGULATION FACTOR IX (HUMAN)
68516-3608	AlphaNine	COAGULATION FACTOR IX (HUMAN)
68516-3609	AlphaNine	COAGULATION FACTOR IX (HUMAN)
68516-3610	AlphaNine	COAGULATION FACTOR IX (HUMAN)
68516-3611	AlphaNine	COAGULATION FACTOR IX (HUMAN)
68516-3612	AlphaNine	COAGULATION FACTOR IX (HUMAN)