FDA.reportPublic FDA data

Nucala

Product NDC
0173-0892
Requested package NDC
0173-0892-01
11-digit product format
001730892
Labeler code
0173
Product ID
0173-0892_8cfc9c7d-1883-49c3-bcd8-44618a791def
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mepolizumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
GlaxoSmithKline LLC
Application
BLA761122
Marketing category
BLA
Marketing start
2019-06-06
Substance
MEPOLIZUMAB
Active strength
100 mg/mL
Pharmacologic classes
Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Nucala
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPOLIZUMAB100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
90Z2UF0E52Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1720601Internal RxNorm lookup
1720606Internal RxNorm lookup
2170990Internal RxNorm lookup
2170993Internal RxNorm lookup
2173820Internal RxNorm lookup
2173822Internal RxNorm lookup
2596444Internal RxNorm lookup
2596445Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fefb887c-e4ac-431e-8893-e9d1a5a63feaAvailable on FDA.report

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
0173-0892-01Nucala1 mL in 1 SYRINGEINJECTION, SOLUTION124
0173-0892-01Nucala1 in 1 CARTONINJECTION, SOLUTION124
0173-0892-42Nucala1 in 1 CARTONINJECTION, SOLUTION124
0173-0892-42Nucala1 mL in 1 SYRINGEINJECTION, SOLUTION124
0173-0892-61Nucala1 mL in 1 SYRINGEINJECTION, SOLUTION124
0173-0892-61Nucala1 in 1 CARTONINJECTION, SOLUTION124
0173-0892-63Nucala1 in 1 CARTONINJECTION, SOLUTION124
0173-0892-63Nucala1 mL in 1 SYRINGEINJECTION, SOLUTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0892-01ML - Milliliter0173-0892ab46c761-196f-4f34-9d83-2926390f6daf12019-07-02
0173-0892-42ML - Milliliter0173-0892476003c6-4a80-469a-938e-aa6c3b1b5d9a12019-07-02
0173-0892-61ML - Milliliter0173-0892ca10c068-ed03-46a9-a6e9-e3992c2b3c9a12022-12-07

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
0173-0892NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION NUCALA (MEPOLIZUMAB) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC]22Current NDC, Legacy NDC, 8 package rows20250524_fefb887c-e4ac-431e-8893-e9d1a5a63fea.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761122Nucalamepolizumab351(a)Rx2026-10-01

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
0173-0892-01001730892011 SYRINGE in 1 CARTON (0173-0892-01) / 1 mL in 1 SYRINGE1 syringe2019-06-060000-00-00NoNoCurrent