FDA.reportPublic FDA data

Nucala

Product NDC
0173-0881
11-digit product format
001730881
Labeler code
0173
Product ID
0173-0881_869b75ba-b2a0-406e-9ed2-136b75763d78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mepolizumab
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
GlaxoSmithKline LLC
Application
BLA125526
Marketing category
BLA
Marketing start
2015-11-04
Substance
MEPOLIZUMAB
Active strength
100 mg/mL
Pharmacologic classes
Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nucala
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPOLIZUMAB100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii90Z2UF0E52
Rxcui1720601, 1720606, 2170990, 2170993, 2173820, 2173822, 2596444, 2596445

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ba65d73-eb90-46f2-816e-82ee2be9e649Product name220190910

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0881-01Nucala1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION124
0173-0881-01Nucala1 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION124
0173-0881-61Nucala1 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION124
0173-0881-61Nucala1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0881-01EA - Each0173-0881ad0b6dbf-7593-44dc-9f41-0675bdacd8e612015-12-02
0173-0881-61EA - Each0173-0881f91bc2d7-7cb8-44c0-be40-dd63dea8427c12024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEPOLIZUMABACTIVE INGREDIENT90Z2UF0E52NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC]2
MEPOLIZUMABACTIVE MOIETY90Z2UF0E52NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC]2
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BNUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0881NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION NUCALA (MEPOLIZUMAB) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC]22Current NDC, Legacy NDC, 4 package rows20250524_fefb887c-e4ac-431e-8893-e9d1a5a63fea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2170990mepolizumab 100 MG in 1 mL Auto-InjectorPSNfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2173820mepolizumab 100 MG in 1 mL Prefilled SyringePSNfefb887c-e4ac-431e-8893-e9d1a5a63fea24
1720601mepolizumab 100 MG InjectionPSNfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2596444mepolizumab 40 MG in 0.4 ML Prefilled SyringePSNfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2170993Nucala 100 MG in 1 mL Auto-InjectorPSNfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2173822Nucala 100 MG in 1 mL Prefilled SyringePSNfefb887c-e4ac-431e-8893-e9d1a5a63fea24
1720606Nucala 100 MG InjectionPSNfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2596445Nucala 40 MG in 0.4 ML Prefilled SyringePSNfefb887c-e4ac-431e-8893-e9d1a5a63fea24
25964450.4 ML mepolizumab 100 MG/ML Prefilled Syringe [Nucala]SBDfefb887c-e4ac-431e-8893-e9d1a5a63fea24
21709931 ML mepolizumab 100 MG/ML Auto-Injector [Nucala]SBDfefb887c-e4ac-431e-8893-e9d1a5a63fea24
21738221 ML mepolizumab 100 MG/ML Prefilled Syringe [Nucala]SBDfefb887c-e4ac-431e-8893-e9d1a5a63fea24
1720606mepolizumab 100 MG Injection [Nucala]SBDfefb887c-e4ac-431e-8893-e9d1a5a63fea24
25964440.4 ML mepolizumab 100 MG/ML Prefilled SyringeSCDfefb887c-e4ac-431e-8893-e9d1a5a63fea24
21709901 ML mepolizumab 100 MG/ML Auto-InjectorSCDfefb887c-e4ac-431e-8893-e9d1a5a63fea24
21738201 ML mepolizumab 100 MG/ML Prefilled SyringeSCDfefb887c-e4ac-431e-8893-e9d1a5a63fea24
1720601mepolizumab 100 MG InjectionSCDfefb887c-e4ac-431e-8893-e9d1a5a63fea24
25964450.4 ML Nucala 100 MG/ML Prefilled SyringeSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
21709931 ML Nucala 100 MG/ML Auto-InjectorSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
21738221 ML Nucala 100 MG/ML Prefilled SyringeSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2170990mepolizumab 100 MG per 1 ML Auto-InjectorSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2173820mepolizumab 100 MG per 1 ML Prefilled SyringeSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2596444mepolizumab 40 MG per 0.4 ML Prefilled SyringeSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
1720606Nucala 100 MG InjectionSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2170993Nucala 100 MG per 1 ML Auto-InjectorSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2173822Nucala 100 MG per 1 ML Prefilled SyringeSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24
2596445Nucala 40 MG per 0.4 ML Prefilled SyringeSYfefb887c-e4ac-431e-8893-e9d1a5a63fea24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0881-01001730881011 VIAL in 1 CARTON (0173-0881-01) / 1 mL in 1 VIAL1 vial2015-11-040000-00-00NoNoCurrent
0173-0881-61001730881611 VIAL in 1 CARTON (0173-0881-61) / 1 mL in 1 VIAL1 vial2016-06-170000-00-00NoNoCurrent