NDC 68012-350

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 Santarus, Inc.. The primary component is Conestat Alfa.

• Product ID: 68012-350_1ee71ee6-7d7a-4543-bb0f-4b463801b5e1
• NDC: 68012-350
• 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: 2014-09-22
• Marketing End Date: 2022-01-18
• Marketing Category: BLA / BLA
• Application Number: BLA125495
• Labeler Name: Santarus, Inc.
• Substance Name: CONESTAT ALFA
• Active Ingredient Strength: 2100 U/1
• NDC Exclude Flag: N

Packaging

NDC 68012-350-02

1 VIAL, SINGLE-USE in 1 CARTON (68012-350-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (68012-350-01)

• Marketing Start Date: 2014-09-22
• Marketing End Date: 2022-01-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68012-350-01 [68012035001]

Ruconest INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125495
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-22
• Marketing End Date: 2022-01-18

NDC 68012-350-02 [68012035002]

Ruconest INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125495
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-22
• Marketing End Date: 2022-01-18

Drug Details

Active Ingredients

Ingredient	Strength
CONESTAT ALFA	2100 U/1

OpenFDA Data

• SPL SET ID: 6f8b81df-48fe-4798-8d54-fc8f65888489
• Manufacturer:
  • Santarus, Inc.
• 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