EMGALITY

Product NDC: 0002-3115
Requested package NDC: 0002-3115-00
11-digit product format: 000023115
Labeler code: 0002
Product ID: 0002-3115_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: 2019-06-04
Substance: GALCANEZUMAB
Active strength: 100 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0002-3115	0002-3115-00	UNFINISHED	Active or certified unfinished drug listing		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`

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
Ingredient	Strength
GALCANEZUMAB	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
55KHL3P693	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
33a147be-233a-40e8-a55e-e40936e28db0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ac54c6d-1672-4959-9dd1-1a375d154b3d	Product name	1	20190103
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0002-3115-01	EMGALITY	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1		15
0002-3115-09	EMGALITY	3 in 1 CARTON	INJECTION, SOLUTION	3		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-3115-01	ML - Milliliter	0002-3115	ef39b935-734f-47a0-85d4-3f35940b0a2e	1	2019-07-02
0002-3115-09	ML - Milliliter	0002-3115	7b6753c2-fec3-4f57-aab9-5aeccb893bda	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-3115	EMGALITY (GALCANEZUMAB-GNLM) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	13	Current NDC, Legacy NDC, 2 package rows	20250403_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EMGALITY	GALCANEZUMAB-GNLM	Eli Lilly and Company	33a147be-233a-40e8-a55e-e40936e28db0	2026-06-05	Warnings, Adverse reactions	Exact identifier application number: BLA761063 ndc (product): 0002-3115

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761063	Emgality	galcanezumab-gnlm	351(a)	Rx	2026-09-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
55KHL3P693	GALCANEZUMAB	1578199-75-3	GALCANEZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2170613	Emgality 100 MG in 1 ML Prefilled Syringe	PSN	33a147be-233a-40e8-a55e-e40936e28db0	15
2058877	Emgality 120 MG in 1 ML Auto-Injector	PSN	33a147be-233a-40e8-a55e-e40936e28db0	15
2058887	Emgality 120 MG in 1 ML Prefilled Syringe	PSN	33a147be-233a-40e8-a55e-e40936e28db0	15
2170611	galcanezumab-gnlm 100 MG in 1 ML Prefilled Syringe	PSN	33a147be-233a-40e8-a55e-e40936e28db0	15
2058872	galcanezumab-gnlm 120 MG in 1 ML Auto-Injector	PSN	33a147be-233a-40e8-a55e-e40936e28db0	15
2058885	galcanezumab-gnlm 120 MG in 1 ML Prefilled Syringe	PSN	33a147be-233a-40e8-a55e-e40936e28db0	15
2170613	1 ML galcanezumab-gnlm 100 MG/ML Prefilled Syringe [Emgality]	SBD	33a147be-233a-40e8-a55e-e40936e28db0	15
2058877	1 ML galcanezumab-gnlm 120 MG/ML Auto-Injector [Emgality]	SBD	33a147be-233a-40e8-a55e-e40936e28db0	15
2058887	1 ML galcanezumab-gnlm 120 MG/ML Prefilled Syringe [Emgality]	SBD	33a147be-233a-40e8-a55e-e40936e28db0	15
2170611	1 ML galcanezumab-gnlm 100 MG/ML Prefilled Syringe	SCD	33a147be-233a-40e8-a55e-e40936e28db0	15
2058872	1 ML galcanezumab-gnlm 120 MG/ML Auto-Injector	SCD	33a147be-233a-40e8-a55e-e40936e28db0	15
2058885	1 ML galcanezumab-gnlm 120 MG/ML Prefilled Syringe	SCD	33a147be-233a-40e8-a55e-e40936e28db0	15
2170613	1 ML Emgality 100 MG/ML Prefilled Syringe	SY	33a147be-233a-40e8-a55e-e40936e28db0	15
2170613	Emgality 100 MG per 1 ML Prefilled Syringe	SY	33a147be-233a-40e8-a55e-e40936e28db0	15
2058877	Emgality 120 MG per 1 ML Auto-Injector	SY	33a147be-233a-40e8-a55e-e40936e28db0	15
2058887	Emgality 120 MG per 1 ML Prefilled Syringe	SY	33a147be-233a-40e8-a55e-e40936e28db0	15
2058872	galcanezumab-gnlm 120 MG per 1 ML Auto-Injector	SY	33a147be-233a-40e8-a55e-e40936e28db0	15
2058885	galcanezumab-gnlm 120 MG per 1 ML Prefilled Syringe	SY	33a147be-233a-40e8-a55e-e40936e28db0	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
0002-3115-00	00002311500	1 mL in 1 SYRINGE (0002-3115-00)	1 ml	04-JUN-19	Current