NDC 0173-0892

Nucala

Mepolizumab

Nucala is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Mepolizumab.

• Product ID: 0173-0892_446a68b1-6766-4906-8419-b203b17c429e
• NDC: 0173-0892
• Product Type: Human Prescription Drug
• Proprietary Name: Nucala
• Generic Name: Mepolizumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-06-06
• Marketing Category: BLA / BLA
• Application Number: BLA761122
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: MEPOLIZUMAB
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Interleukin-5 Antagonist [EPC],Interleukin-5 Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0173-0892-01

1 SYRINGE in 1 CARTON (0173-0892-01) > 1 mL in 1 SYRINGE

• Marketing Start Date: 2019-06-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0892-42 [00173089242]

Nucala INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761122
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-06

NDC 0173-0892-01 [00173089201]

Nucala INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761122
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-06

NDC 0173-0892-61 [00173089261]

Nucala INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761122
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-06

NDC 0173-0892-63 [00173089263]

Nucala INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761122
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-06

Drug Details

Active Ingredients

Ingredient	Strength
MEPOLIZUMAB	100 mg/mL

OpenFDA Data

• SPL SET ID: fefb887c-e4ac-431e-8893-e9d1a5a63fea
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 90Z2UF0E52
• RxNorm Concept Unique ID - RxCUI:
  • 1720606
  • 1720601

Pharmacological Class

• Interleukin-5 Antagonist [EPC]
• Interleukin-5 Antagonists [MoA]

NDC Crossover Matching brand name "Nucala" or generic name "Mepolizumab"

NDC	Brand Name	Generic Name
0173-0881	Nucala	mepolizumab
0173-0892	Nucala	mepolizumab
0173-0904	Nucala	mepolizumab