FDA.reportPublic FDA data

EMGALITY

Product NDC
0002-1436
Requested package NDC
0002-1436-61
11-digit product format
000021436
Labeler code
0002
Product ID
0002-1436_b58a1b24-8a42-4073-9413-4f9b7c308a64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
galcanezumab-gnlm
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA761063
Marketing category
BLA
Marketing start
2018-09-27
Substance
GALCANEZUMAB
Active strength
120 mg/mL
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
EMGALITY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALCANEZUMAB120 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55KHL3P693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2058872Internal RxNorm lookup
2058877Internal RxNorm lookup
2058885Internal RxNorm lookup
2058887Internal RxNorm lookup
2170611Internal RxNorm lookup
2170613Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33a147be-233a-40e8-a55e-e40936e28db0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ac54c6d-1672-4959-9dd1-1a375d154b3dProduct name120190103
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-1436-01EMGALITY1 mL in 1 SYRINGEINJECTION, SOLUTION115
0002-1436-11EMGALITY1 in 1 CARTONINJECTION, SOLUTION115
0002-1436-27EMGALITY2 in 1 CARTONINJECTION, SOLUTION215
0002-1436-61EMGALITY2 in 1 CARTONINJECTION, SOLUTION215
0002-1436-61EMGALITY1 mL in 1 SYRINGEINJECTION, SOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-1436-01ML - Milliliter0002-1436222b1042-56d0-4455-badb-2691ff198aa012018-10-11
0002-1436-11ML - Milliliter0002-1436af8e2206-e54b-4595-9964-4089a5eb912e12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-1436EMGALITY (GALCANEZUMAB-GNLM) INJECTION, SOLUTION [ELI LILLY AND COMPANY]13Current NDC, Legacy NDC, 5 package rows20250403_33a147be-233a-40e8-a55e-e40936e28db0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMGALITYGALCANEZUMAB-GNLMEli Lilly and Company33a147be-233a-40e8-a55e-e40936e28db02026-06-05Warnings, Adverse reactionsExact identifier
application number: BLA761063
ndc (package): 0002-1436-61
ndc (product): 0002-1436
ndc11 (package): 00002143661

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761063Emgalitygalcanezumab-gnlm351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2170613Emgality 100 MG in 1 ML Prefilled SyringePSN33a147be-233a-40e8-a55e-e40936e28db015
2058877Emgality 120 MG in 1 ML Auto-InjectorPSN33a147be-233a-40e8-a55e-e40936e28db015
2058887Emgality 120 MG in 1 ML Prefilled SyringePSN33a147be-233a-40e8-a55e-e40936e28db015
2170611galcanezumab-gnlm 100 MG in 1 ML Prefilled SyringePSN33a147be-233a-40e8-a55e-e40936e28db015
2058872galcanezumab-gnlm 120 MG in 1 ML Auto-InjectorPSN33a147be-233a-40e8-a55e-e40936e28db015
2058885galcanezumab-gnlm 120 MG in 1 ML Prefilled SyringePSN33a147be-233a-40e8-a55e-e40936e28db015
21706131 ML galcanezumab-gnlm 100 MG/ML Prefilled Syringe [Emgality]SBD33a147be-233a-40e8-a55e-e40936e28db015
20588771 ML galcanezumab-gnlm 120 MG/ML Auto-Injector [Emgality]SBD33a147be-233a-40e8-a55e-e40936e28db015
20588871 ML galcanezumab-gnlm 120 MG/ML Prefilled Syringe [Emgality]SBD33a147be-233a-40e8-a55e-e40936e28db015
21706111 ML galcanezumab-gnlm 100 MG/ML Prefilled SyringeSCD33a147be-233a-40e8-a55e-e40936e28db015
20588721 ML galcanezumab-gnlm 120 MG/ML Auto-InjectorSCD33a147be-233a-40e8-a55e-e40936e28db015
20588851 ML galcanezumab-gnlm 120 MG/ML Prefilled SyringeSCD33a147be-233a-40e8-a55e-e40936e28db015
21706131 ML Emgality 100 MG/ML Prefilled SyringeSY33a147be-233a-40e8-a55e-e40936e28db015
2170613Emgality 100 MG per 1 ML Prefilled SyringeSY33a147be-233a-40e8-a55e-e40936e28db015
2058877Emgality 120 MG per 1 ML Auto-InjectorSY33a147be-233a-40e8-a55e-e40936e28db015
2058887Emgality 120 MG per 1 ML Prefilled SyringeSY33a147be-233a-40e8-a55e-e40936e28db015
2058872galcanezumab-gnlm 120 MG per 1 ML Auto-InjectorSY33a147be-233a-40e8-a55e-e40936e28db015
2058885galcanezumab-gnlm 120 MG per 1 ML Prefilled SyringeSY33a147be-233a-40e8-a55e-e40936e28db015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-1436-61000021436612 SYRINGE in 1 CARTON (0002-1436-61) / 1 mL in 1 SYRINGE2 syringe2018-09-270000-00-00YesNoCurrent