Brekiya Injection
NDC Package 64896-509-02

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

Package Information

Brekiya (dihydroergotamine mesylate) injection is dihydroergotamine is used to treat migraine headaches and cluster headaches. This formulation utilizes a injection delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 64896-509 and is authorized under FDA application NDA215400.

Identification & Billing

NDC Package Code
64896-509-02
Package Description
4 POUCH in 1 CARTON / 1 SYRINGE in 1 POUCH / 1 mL in 1 SYRINGE (64896-509-01)
Product Code
64896-509
11-Digit Billing Format
64896050902
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2714308 - dihydroergotamine mesylate 1 MG in 1 ML Auto-Injector
  • RxCUI: 2714308 - 1 ML dihydroergotamine mesylate 1 MG/ML Auto-Injector
  • RxCUI: 2714308 - 1 ML DHE mesylate 1 MG/ML Auto-Injector
  • RxCUI: 2714308 - dihydroergotamine mesylate 1 MG (equivalent to dihydroergotamine 0.86 MG) per 1 ML Auto-Injector
  • RxCUI: 2714315 - brekiya 1 MG in 1 ML Auto-Injector

Clinical Specifications

Proprietary Name
Brekiya
Non-Proprietary Name
Dihydroergotamine Mesylate
Substance Name
Dihydroergotamine Mesylate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
DIHYDROERGOTAMINE MESYLATE 1 mg/mL
Pharmacologic Class
Usage Information
Dihydroergotamine is used to treat migraine headaches and cluster headaches. It is not recommended for migraines that affect only one side of the brain (hemiplegic migraine) or the base of the brain/neck area (basilar migraine), or to prevent migraines from occurring. Dihydroergotamine is an ergot medication that helps narrow widened blood vessels in the head, thereby reducing the throbbing effects of these headaches.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA215400
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-16-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64896-509-02 identifies a specific commercial package of 4 pouch in 1 carton / 1 syringe in 1 pouch / 1 ml in 1 syringe (64896-509-01) of Brekiya, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This injection is formulated for subcutaneous use and contains dihydroergotamine mesylate 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 Amneal Pharmaceuticals Llc on May 16, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Dihydroergotamine is used to treat migraine headaches and cluster headaches. It is not recommended for migraines that affect only one side of the brain (hemiplegic migraine) or the base of the brain/neck area (basilar migraine), or to prevent migraines from occurring. Dihydroergotamine is an ergot medication that helps narrow widened blood vessels in the head, thereby reducing the throbbing effects of these headaches.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64896050902. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
64896-509-02
11-Digit CMS (5-4-2)
64896-0509-02

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