NDC 47783-644

TAKHZYRO

Lanadelumab-flyo

TAKHZYRO is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Dyax Corp.. The primary component is Lanadelumab.

• Product ID: 47783-644_13afb1d4-a38b-4d60-84e6-c1ee366cd45e
• NDC: 47783-644
• Product Type: Human Prescription Drug
• Proprietary Name: TAKHZYRO
• Generic Name: Lanadelumab-flyo
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-08-24
• Marketing Category: BLA / BLA
• Application Number: BLA761090
• Labeler Name: Dyax Corp.
• Substance Name: LANADELUMAB
• Active Ingredient Strength: 300 mg/2mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 47783-644-01

1 VIAL, GLASS in 1 CARTON (47783-644-01) > 5 mL in 1 VIAL, GLASS

• Marketing Start Date: 2018-08-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47783-644-01 [47783064401]

TAKHZYRO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761090
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-08-24

Drug Details

Active Ingredients

Ingredient	Strength
LANADELUMAB	300 mg/2mL

OpenFDA Data

• SPL SET ID: 15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e8
• Manufacturer:
  • Dyax Corp.
• UNII:
  • 2372V1TKXK
• RxNorm Concept Unique ID - RxCUI:
  • 2055645
  • 2055650

NDC Crossover Matching brand name "TAKHZYRO" or generic name "Lanadelumab-flyo"

NDC	Brand Name	Generic Name
47783-644	TAKHZYRO	lanadelumab-flyo
47783-646	TAKHZYRO	lanadelumab-flyo