NDC 0002-2377
EMGALITY
Galcanezumab-gnlm
EMGALITY is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Galcanezumab.
| Product ID | 0002-2377_4b767820-97fe-430d-8e77-6047e82ac81e |
| NDC | 0002-2377 |
| Product Type | Human Prescription Drug |
| Proprietary Name | EMGALITY |
| Generic Name | Galcanezumab-gnlm |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2018-09-27 |
| Marketing Category | BLA / BLA |
| Application Number | BLA761063 |
| Labeler Name | Eli Lilly and Company |
| Substance Name | GALCANEZUMAB |
| Active Ingredient Strength | 120 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0002-2377-11
1 SYRINGE in 1 CARTON (0002-2377-11) > 1 mL in 1 SYRINGE (0002-2377-01)
| Marketing Start Date | 2019-01-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0002-2377-01 [00002237701]
EMGALITY INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761063 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-09-27 |
NDC 0002-2377-11 [00002237711]
EMGALITY INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761063 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-01-18 |
NDC 0002-2377-27 [00002237727]
EMGALITY INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761063 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-09-27 |
| Marketing End Date | 2018-09-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GALCANEZUMAB | 120 mg/mL |
OpenFDA Data
| SPL SET ID: | 33a147be-233a-40e8-a55e-e40936e28db0 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "EMGALITY" or generic name "Galcanezumab-gnlm"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0002-1436 | EMGALITY | galcanezumab-gnlm |
| 0002-2377 | EMGALITY | galcanezumab-gnlm |
| 0002-3115 | EMGALITY | galcanezumab-gnlm |
Trademark Results [EMGALITY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMGALITY 88112647 not registered Live/Pending |
Eli Lilly and Company 2018-09-11 |
 EMGALITY 87435081 5633683 Live/Registered |
Eli Lilly and Company 2017-05-03 |
 EMGALITY 87263356 5628446 Live/Registered |
Eli Lilly and Company 2016-12-09 |
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