NDC 71394-415

LUXTURNA

Voretigene Neparvovec-rzyl

LUXTURNA is a Kit in the Human Prescription Drug category. It is labeled and distributed by Spark Therapeutics, Inc.. The primary component is .

• Product ID: 71394-415_512ef6fb-1997-4fcb-b817-9b0a8c47147a
• NDC: 71394-415
• Product Type: Human Prescription Drug
• Proprietary Name: LUXTURNA
• Generic Name: Voretigene Neparvovec-rzyl
• Dosage Form: Kit
• Marketing Start Date: 2017-12-19
• Marketing Category: BLA / BLA
• Application Number: BLA125610
• Labeler Name: Spark Therapeutics, Inc.
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71394-415-01

1 KIT in 1 CARTON (71394-415-01) * 1 INJECTION, SUSPENSION in 1 VIAL, PLASTIC (71394-065-01) * 1 INJECTION, SOLUTION in 1 VIAL, PLASTIC (71394-716-01)

• Marketing Start Date: 2017-12-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71394-415-01 [71394041501]

LUXTURNA KIT

• Marketing Category: BLA
• Application Number: BLA125610
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-12-19

Drug Details

OpenFDA Data

• SPL SET ID: 08313a24-e7ce-457a-bb3f-161bc45517ee
• Manufacturer:
  • Spark Therapeutics, Inc.
• RxNorm Concept Unique ID - RxCUI:
  • 1995886
  • 1995884