NDC 50242-921

Hemlibra

Emicizumab

Hemlibra is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Emicizumab.

• Product ID: 50242-921_10a84bba-6ac6-4a54-9c2b-55d39a232d59
• NDC: 50242-921
• Product Type: Human Prescription Drug
• Proprietary Name: Hemlibra
• Generic Name: Emicizumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-11-16
• Marketing Category: BLA / BLA
• Application Number: BLA761083
• Labeler Name: Genentech, Inc.
• Substance Name: EMICIZUMAB
• Active Ingredient Strength: 150 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50242-921-01

1 VIAL, SINGLE-USE in 1 CARTON (50242-921-01) > .4 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2017-11-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-921-01 [50242092101]

Hemlibra INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761083
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-16

Drug Details

Active Ingredients

Ingredient	Strength
EMICIZUMAB	150 mg/mL

OpenFDA Data

• SPL SET ID: 2483adba-fab6-4d1b-96c5-c195577ed071
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • 7NL2E3F6K3
• RxNorm Concept Unique ID - RxCUI:
  • 1989804
  • 1989809
  • 1989811
  • 1989799
  • 1989815
  • 1989814
  • 1989817
  • 1989816

NDC Crossover Matching brand name "Hemlibra" or generic name "Emicizumab"

NDC	Brand Name	Generic Name
50242-920	Hemlibra	emicizumab
50242-921	Hemlibra	emicizumab
50242-922	Hemlibra	emicizumab
50242-923	Hemlibra	emicizumab