NDC 69794-203

CRYSVITA

Burosumab

CRYSVITA is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Ultragenyx Pharmaceutical Inc.. The primary component is Burosumab.

• Product ID: 69794-203_81078e03-384d-40f9-a5e9-9b8b49163a32
• NDC: 69794-203
• Product Type: Human Prescription Drug
• Proprietary Name: CRYSVITA
• Generic Name: Burosumab
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-04-18
• Marketing Category: BLA / BLA
• Application Number: BLA761068
• Labeler Name: Ultragenyx Pharmaceutical Inc.
• Substance Name: BUROSUMAB
• Active Ingredient Strength: 20 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 69794-203-01

1 mL in 1 VIAL, SINGLE-USE (69794-203-01)

• Marketing Start Date: 2018-04-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69794-203-01 [69794020301]

CRYSVITA INJECTION

• Marketing Category: BLA
• Application Number: BLA761068
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-04-18

Drug Details

Active Ingredients

Ingredient	Strength
BUROSUMAB	20 mg/mL

OpenFDA Data

• SPL SET ID: 6f5f3556-3197-477a-993c-96b2c29a91ac
• Manufacturer:
  • Ultragenyx Pharmaceutical Inc.
• UNII:
  • G9WJT6RD29
• RxNorm Concept Unique ID - RxCUI:
  • 2043876
  • 2043870
  • 2043864
  • 2043868
  • 2043878
  • 2043859

NDC Crossover Matching brand name "CRYSVITA" or generic name "Burosumab"

NDC	Brand Name	Generic Name
69794-102	CRYSVITA	Burosumab
69794-203	CRYSVITA	Burosumab
69794-304	CRYSVITA	Burosumab