NDC 0169-7901

REBINYN

(coagulation Factor Ix (recombinant), Glycopegylated)

REBINYN is a Kit in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is .

• Product ID: 0169-7901_2df3f725-b51f-4984-976f-e3069d69210f
• NDC: 0169-7901
• Product Type: Human Prescription Drug
• Proprietary Name: REBINYN
• Generic Name: (coagulation Factor Ix (recombinant), Glycopegylated)
• Dosage Form: Kit
• Marketing Start Date: 2017-12-01
• Marketing Category: BLA / BLA
• Application Number: BLA125611
• Labeler Name: Novo Nordisk
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0169-7901-01

1 KIT in 1 KIT (0169-7901-01) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11)

• Marketing Start Date: 2017-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0169-7901-01 [00169790101]

REBINYN KIT

• Marketing Category: BLA
• Application Number: BLA125611
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-01

Drug Details

OpenFDA Data

• SPL SET ID: 0ea37235-35fd-410d-b8c4-40ba15fe1294
• Manufacturer:
  • Novo Nordisk
• RxNorm Concept Unique ID - RxCUI:
  • 1990857
  • 1990862

NDC Crossover Matching brand name "REBINYN" or generic name "(coagulation Factor Ix (recombinant), Glycopegylated)"

NDC	Brand Name	Generic Name
0169-7901	REBINYN	(Coagulation Factor IX (Recombinant), GlycoPEGylated)
0169-7902	REBINYN	(Coagulation Factor IX (Recombinant), GlycoPEGylated)
0169-7903	REBINYN	(Coagulation Factor IX (Recombinant), GlycoPEGylated)
0169-7905	REBINYN	(Coagulation Factor IX (Recombinant), GlycoPEGylated)