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NDC 00173-0892-42 Nucala 100 mg/mL Details
Nucala 100 mg/mL
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.
MedlinePlus Drug Summary
Mepolizumab injection is used along with other medications to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in certain children 6 years of age and older and adults whose asthma is not controlled with their current asthma medication(s). Mepolizumab injection is also used along with other medications to treat chronic rhinosinusitis with nasal polyps (ongoing runny nose, sinus swelling or nasal congestion, with or without a reduced sense of smell or pain and pressure in the face) in adults whose symptoms are not controlled with other medications. It is also used to treat eosinophilic granulomatosis with polyangiitis (EGPA; a condition that involves asthma, high levels of white blood cells, and blood vessel swelling) in adults. Mepolizumab injection is also used to treat hypereosinophilic syndrome (HES; group of blood disorders that occurs with high levels of certain white blood cells) in adults and children 12 years and older who have had this condition for 6 months or longer. Mepolizumab injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes the symptoms of asthma.
Related Packages: 00173-0892-42Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mepolizumab Injection
Product Information
NDC | 00173-0892 |
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Product ID | 0173-0892_6aaacdeb-43d4-4367-9d37-a9d6876344f1 |
Associated GPIs | 4460405500D530 4460405500E530 |
GCN Sequence Number | 079829 |
GCN Sequence Number Description | mepolizumab AUTO INJCT 100 MG/ML SUBCUT |
HIC3 | Z20 |
HIC3 Description | INTERLEUKIN-5 (IL-5) ANTAGONISTS, MAB |
GCN | 46414 |
HICL Sequence Number | 042775 |
HICL Sequence Number Description | MEPOLIZUMAB |
Brand/Generic | Brand |
Proprietary Name | Nucala |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | mepolizumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | SUBCUTANEOUS |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/mL |
Substance Name | MEPOLIZUMAB |
Labeler Name | GlaxoSmithKline LLC |
Pharmaceutical Class | Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA761122 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00173-0892-42 (00173089242)
NDC Package Code | 0173-0892-42 |
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Billing NDC | 00173089242 |
Package | 1 SYRINGE in 1 CARTON (0173-0892-42) / 1 mL in 1 SYRINGE |
Marketing Start Date | 2019-06-06 |
NDC Exclude Flag | N |
Pricing Information | N/A |