nucala

Generic: mepolizumab

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name nucala
Generic Name mepolizumab
Labeler glaxosmithkline llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

mepolizumab 100 mg/mL

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0892
Product ID 0173-0892_869b75ba-b2a0-406e-9ed2-136b75763d78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761122
Listing Expiration 2026-12-31
Marketing Start 2019-06-06

Pharmacologic Class

Established (EPC)
interleukin-5 antagonist [epc]
Mechanism of Action
interleukin-5 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730892
Hyphenated Format 0173-0892

Supplemental Identifiers

RxCUI
1720601 1720606 2170990 2170993 2173820 2173822 2596444 2596445
UNII
90Z2UF0E52
NUI
N0000191872 N0000191871

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nucala (source: ndc)
Generic Name mepolizumab (source: ndc)
Application Number BLA761122 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0173-0892-01) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (0173-0892-42) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (0173-0892-61) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (0173-0892-63) / 1 mL in 1 SYRINGE
source: ndc

Packages (4)

0173-0892-01 1 SYRINGE in 1 CARTON (0173-0892-01) / 1 mL in 1 SYRINGE 0173-0892-42 1 SYRINGE in 1 CARTON (0173-0892-42) / 1 mL in 1 SYRINGE 0173-0892-61 1 SYRINGE in 1 CARTON (0173-0892-61) / 1 mL in 1 SYRINGE 0173-0892-63 1 SYRINGE in 1 CARTON (0173-0892-63) / 1 mL in 1 SYRINGE

Ingredients (1)

mepolizumab (100 mg/mL)

Linked Drug Pages (1)

Nucala ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "869b75ba-b2a0-406e-9ed2-136b75763d78", "openfda": {"nui": ["N0000191872", "N0000191871"], "unii": ["90Z2UF0E52"], "rxcui": ["1720601", "1720606", "2170990", "2170993", "2173820", "2173822", "2596444", "2596445"], "spl_set_id": ["fefb887c-e4ac-431e-8893-e9d1a5a63fea"], "pharm_class_epc": ["Interleukin-5 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-5 Antagonists [MoA]"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (0173-0892-01)  / 1 mL in 1 SYRINGE", "package_ndc": "0173-0892-01", "marketing_start_date": "20190606"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (0173-0892-42)  / 1 mL in 1 SYRINGE", "package_ndc": "0173-0892-42", "marketing_start_date": "20190606"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (0173-0892-61)  / 1 mL in 1 SYRINGE", "package_ndc": "0173-0892-61", "marketing_start_date": "20190606"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (0173-0892-63)  / 1 mL in 1 SYRINGE", "package_ndc": "0173-0892-63", "marketing_start_date": "20190606"}], "brand_name": "Nucala", "product_id": "0173-0892_869b75ba-b2a0-406e-9ed2-136b75763d78", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-5 Antagonist [EPC]", "Interleukin-5 Antagonists [MoA]"], "product_ndc": "0173-0892", "generic_name": "mepolizumab", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nucala", "active_ingredients": [{"name": "MEPOLIZUMAB", "strength": "100 mg/mL"}], "application_number": "BLA761122", "marketing_category": "BLA", "marketing_start_date": "20190606", "listing_expiration_date": "20261231"}