NDC 0074-0034

Zinbryta Pen

Daclizumab

Zinbryta Pen is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Abbvie. The primary component is Daclizumab.

• Product ID: 0074-0034_44238333-9880-413b-9a9e-1f2b09e0fd6a
• NDC: 0074-0034
• Product Type: Human Prescription Drug
• Proprietary Name: Zinbryta Pen
• Generic Name: Daclizumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-05-26
• Marketing End Date: 2019-10-31
• Marketing Category: BLA / BLA
• Application Number: BLA761029
• Labeler Name: Abbvie
• Substance Name: DACLIZUMAB
• Active Ingredient Strength: 150 mg/mL
• Pharm Classes: Interleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0074-0034-01

1 SYRINGE, GLASS in 1 BOX (0074-0034-01) > 1 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2017-05-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0074-0034-01 [00074003401]

Zinbryta Pen INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761029
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-26
• Marketing End Date: 2019-10-31

Drug Details

Active Ingredients

Ingredient	Strength
DACLIZUMAB	150 mg/mL

OpenFDA Data

• SPL SET ID: 6ced5f68-cb45-44d2-b88a-f5edd2761137
• Manufacturer:
  • Abbvie
• UNII:
  • CUJ2MVI71Y
• RxNorm Concept Unique ID - RxCUI:
  • 1925211
  • 1795339
  • 1925209
  • 1795334

Pharmacological Class

• Interleukin 2 Receptor Antagonists [MoA]
• Interleukin 2 Receptor-directed Antibody Interactions [MoA]
• Interleukin-2 Receptor Blocking Antibody [EPC]

NDC Crossover Matching brand name "Zinbryta Pen" or generic name "Daclizumab"

NDC	Brand Name	Generic Name
0074-0033	Zinbryta	Daclizumab
0074-0034	Zinbryta	Daclizumab