Prescription drug · BLA
Emgality (galcanezumab-gnlm) NDC 0002-1436
Galcanezumab 120 mg/mL · Injection, Solution · Subcutaneous · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-1436-11 | 00002143611 | 1 SYRINGE in 1 CARTON (0002-1436-11) / 1 mL in 1 SYRINGE (0002-1436-01)Marketed from Sep 27, 2018 | |
| 0002-1436-61 | 00002143661 | 2 SYRINGE in 1 CARTON (0002-1436-61) / 1 mL in 1 SYRINGEMarketed from Sep 27, 2018 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Emgality
- Generic name (nonproprietary)
- galcanezumab-gnlm
- Active ingredients
- Galcanezumab — 120 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761063
- Marketing start
- Listing expires
- Identifiers
- Product ID 0002-1436_b58a1b24-8a42-4073-9413-4f9b7c308a64SPL ID b58a1b24-8a42-4073-9413-4f9b7c308a64SPL set ID 33a147be-233a-40e8-a55e-e40936e28db0RxCUI 2058872, 2058877, 2058885, 2058887, 2170611, 2170613UNII 55KHL3P693
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400002143611followed by a unit qualifier and the quantityPackage 00002-1436-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache. ( 1.2 ) 1.1 Migraine EMGALITY is indicated for the preventive treatment of migraine in adults. 1.2 Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761063
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Emgalitygalcanezumab-gnlm | Galcanezumab 120 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-2377 |
| Emgalitygalcanezumab-gnlm | Galcanezumab 100 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-3115 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.