Emgality Injection, Solution
NDC Package 0002-3115-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Emgality (galcanezumab-gnlm) injection is a medication used to help prevent migraine. This formulation utilizes a injection, solution delivery system. Marketed by Eli Lilly And Company, this product is identified by NDC 0002-3115 and is authorized under FDA application BLA761063.

Identification & Billing

NDC Package Code
0002-3115-00
Package Description
1 mL in 1 SYRINGE
Product Code
0002-3115
11-Digit Billing Format
00002311500

Clinical Specifications

Proprietary Name
Emgality
Non-Proprietary Name
Galcanezumab-gnlm
Substance Name
Galcanezumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Usage Information
This medication is used to help prevent migraine. It is also used to treat a certain type of headache (episodic cluster headache). Galcanezumab-gnlm belongs to a class of drugs known as monoclonal antibodies. This medication may work by changing the amounts of certain natural substances in the brain. Using this medication can help improve your ability to concentrate and do your usual tasks.

Regulatory & Marketing

Labeler Name
Eli Lilly And Company
Product Type
Human Prescription Drug
FDA Application #
BLA761063
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-04-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
N/A

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0002-3115). Click a package code to view its specific billing and regulatory data.

0002-3115-09
3 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (0002-3115-01)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0002-3115-00 identifies a specific commercial package of 1 ml in 1 syringe of Emgality, a human prescription drug labeled by Eli Lilly And Company. This injection, solution is formulated for subcutaneous use and contains galcanezumab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Eli Lilly And Company on June 04, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to help prevent migraine. It is also used to treat a certain type of headache (episodic cluster headache). Galcanezumab-gnlm belongs to a class of drugs known as monoclonal antibodies. This medication may work by changing the amounts of certain natural substances in the brain. Using this medication can help improve your ability to concentrate and do your usual tasks.

How is this Eli Lilly And Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00002311500. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0002-3115-00
11-Digit CMS (5-4-2)
00002-3115-00

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.