Trudhesa Spray, Metered
NDC Package 77530-725-00

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

Trudhesa (dihydroergotamine mesylate) sprays is dihydroergotamine is used to treat migraine headaches and cluster headaches. This formulation utilizes a spray, metered delivery system. Marketed by Impel Pharmaceuticals Llc, this product is identified by NDC 77530-725 and is authorized under FDA application NDA213436.

Identification & Billing

NDC Package Code
77530-725-00
Package Description
1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS
Product Code
77530-725
11-Digit Billing Format
77530072500
RxNorm Crosswalk
  • RxCUI: 2569836 - dihydroergotamine mesylate 0.725 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 2569836 - DHE mesylate 0.725 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 2569842 - Trudhesa 0.725 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 2569842 - dihydroergotamine mesylate 0.725 MG/ACTUAT Metered Dose Nasal Spray [Trudhesa]
  • RxCUI: 2569842 - DHE mesylate 0.725 MG/ACTUAT Metered Dose Nasal Spray [Trudhesa]

Clinical Specifications

Proprietary Name
Trudhesa
Non-Proprietary Name
Dihydroergotamine Mesylate
Substance Name
Dihydroergotamine Mesylate
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
DIHYDROERGOTAMINE MESYLATE 4 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
Impel Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA213436
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-24-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (77530-725). Click a package code to view its specific billing and regulatory data.

77530-725-04
4 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS

* 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 77530-725-00 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 ml in 1 vial, glass of Trudhesa, a human prescription drug labeled by Impel Pharmaceuticals Llc. This spray, metered is formulated for nasal 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 Impel Pharmaceuticals Llc on September 24, 2021. 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 Impel Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77530072500. 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)
77530-725-00
11-Digit CMS (5-4-2)
77530-0725-00

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