EMGALITY
- Product NDC
- 0002-1436
- 11-digit product format
- 000021436
- Labeler code
- 0002
- Product ID
- 0002-1436_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
- 2018-09-27
- Substance
- GALCANEZUMAB
- Active strength
- 120 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GALCANEZUMAB | 120 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55KHL3P693 |
| Rxcui | 2058872, 2058877, 2058885, 2058887, 2170611, 2170613 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0002-1436-01 | EMGALITY | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 15 |
| 0002-1436-11 | EMGALITY | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 15 |
| 0002-1436-27 | EMGALITY | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 15 |
| 0002-1436-61 | EMGALITY | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 15 |
| 0002-1436-61 | EMGALITY | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0002-1436 | EMGALITY (GALCANEZUMAB-GNLM) INJECTION, SOLUTION [ELI LILLY AND COMPANY] | 13 | Current NDC, Legacy NDC, 5 package rows | 20250403_33a147be-233a-40e8-a55e-e40936e28db0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0002-1436-00 | 00002143600 | 1 mL in 1 SYRINGE (0002-1436-00) | 1 ml | 27-SEP-18 | | | | Current |
| 0002-1436-01 | 00002143601 | 1 mL in 1 SYRINGE | 1 ml | | | | | Historical |
| 0002-1436-11 | 00002143611 | 1 SYRINGE in 1 CARTON (0002-1436-11) / 1 mL in 1 SYRINGE (0002-1436-01) | 1 syringe | 2018-09-27 | 0000-00-00 | No | No | Current |
| 0002-1436-27 | 00002143627 | 2 in 1 CARTON | | | | | | Historical |
| 0002-1436-61 | 00002143661 | 2 SYRINGE in 1 CARTON (0002-1436-61) / 1 mL in 1 SYRINGE | 2 syringe | 2018-09-27 | 0000-00-00 | Yes | No | Current |