NDC 0024-5920

KEVZARA

Sarilumab

KEVZARA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Sarilumab.

• Product ID: 0024-5920_01aea597-9923-4257-9aa6-f6a5f33cf627
• NDC: 0024-5920
• Product Type: Human Prescription Drug
• Proprietary Name: KEVZARA
• Generic Name: Sarilumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-05-22
• Marketing Category: BLA / BLA
• Application Number: BLA761037
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: SARILUMAB
• Active Ingredient Strength: 150 mg/1.14mL
• Pharm Classes: Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0024-5920-01

2 SYRINGE in 1 PACKAGE (0024-5920-01) > 1.14 mL in 1 SYRINGE

• Marketing Start Date: 2018-04-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-5920-02 [00024592002]

KEVZARA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761037
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-04-13

NDC 0024-5920-01 [00024592001]

KEVZARA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761037
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-04-13

Drug Details

Active Ingredients

Ingredient	Strength
SARILUMAB	150 mg/1.14mL

OpenFDA Data

• SPL SET ID: 827bc01c-d379-4266-a18c-c7f904b76af3
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • NU90V55F8I
• RxNorm Concept Unique ID - RxCUI:
  • 1923333
  • 1923338
  • 1923345
  • 1923347
  • 2003755
  • 2003757
  • 2003767
  • 2003766

Pharmacological Class

• Interleukin 6 Receptor Antagonists [MoA]
• Interleukin-6 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "KEVZARA" or generic name "Sarilumab"

NDC	Brand Name	Generic Name
0024-5908	KEVZARA	sarilumab
0024-5910	KEVZARA	sarilumab
0024-5920	KEVZARA	sarilumab
0024-5922	KEVZARA	sarilumab