NDC 69913-350

Ruconest

C1 Esterase Inhibitor Recombinant

Ruconest is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Tjoapack Netherlands Bv. The primary component is Conestat Alfa.

• Product ID: 69913-350_7cefdd94-d2a2-1aac-e053-2991aa0a1e5e
• NDC: 69913-350
• Product Type: Human Prescription Drug
• Proprietary Name: Ruconest
• Generic Name: C1 Esterase Inhibitor Recombinant
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-09-19
• Marketing Category: BLA / BLA
• Application Number: BLA125495
• Labeler Name: Tjoapack Netherlands BV
• Substance Name: CONESTAT ALFA
• Active Ingredient Strength: 2100 U/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69913-350-01

1 VIAL, SINGLE-USE in 1 CARTON (69913-350-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2016-09-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69913-350-01 [69913035001]

Ruconest INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125495
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-19

Drug Details

Active Ingredients

Ingredient	Strength
CONESTAT ALFA	2100 U/1

OpenFDA Data

• SPL SET ID: 3cf4c3f5-5230-277e-e054-00144ff8d46c
• Manufacturer:
  • Tjoapack Netherlands BV
• UNII:
  • 5QS67N4551
• RxNorm Concept Unique ID - RxCUI:
  • 1599836
  • 1599841

NDC Crossover Matching brand name "Ruconest" or generic name "C1 Esterase Inhibitor Recombinant"

NDC	Brand Name	Generic Name
68012-350	Ruconest	c1 esterase inhibitor recombinant
69913-350	Ruconest	c1 esterase inhibitor recombinant
70383-350	Ruconest	c1 esterase inhibitor recombinant
71274-350	Ruconest	c1 esterase inhibitor recombinant