EMGALITY
- Product NDC
- 0002-3115
- 11-digit product format
- 000023115
- Labeler code
- 0002
- Product ID
- 0002-3115_36fde2df-4f86-4823-a2d5-832041e22960
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EMGALITY
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GALCANEZUMAB | 100 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 55KHL3P693 |
| Rxcui | 2058872, 2058877, 2058885, 2058887, 2170611, 2170613 |
DailyMed Product Concepts#
| 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 | 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 | 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#
DailyMed RxNorm Mappings#
| 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0002-3115-00 | 00002311500 | 1 mL in 1 SYRINGE (0002-3115-00) | 1 ml | 04-JUN-19 | Current | |||
| 0002-3115-01 | 00002311501 | 1 mL in 1 SYRINGE | 1 ml | Historical | ||||
| 0002-3115-09 | 00002311509 | 3 SYRINGE in 1 CARTON (0002-3115-09) / 1 mL in 1 SYRINGE (0002-3115-01) | 3 syringe | 2019-06-17 | 0000-00-00 | No | No | Current |