Dihydroergotamine Mesylate Nasal Spray, Metered
NDC Package 69097-503-27

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

Dihydroergotamine Mesylate Nasal sprays is dihydroergotamine is used to treat migraine headaches and cluster headaches. This formulation utilizes a spray, metered delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-503 and is authorized under FDA application ANDA212907.

Identification & Billing

NDC Package Code
69097-503-27
Package Description
8 VIAL in 1 KIT / 1 mL in 1 VIAL
Product Code
69097-503
11-Digit Billing Format
69097050327
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 861668 - dihydroergotamine mesylate 4 MG/mL Metered Dose Nasal Spray
  • RxCUI: 861668 - dihydroergotamine mesylate 0.5 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 861668 - DHE Mesylate 0.5 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 861668 - dihydroergotamine mesylate 0.5 MG/ACTUAT (4 MG/ML) Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Dihydroergotamine Mesylate Nasal
Non-Proprietary Name
Dihydroergotamine Mesylate Nasal
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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212907
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-23-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69097-503). Click a package code to view its specific billing and regulatory data.

69097-503-31
1 VIAL in 1 KIT / 1 mL in 1 VIAL

* 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 69097-503-27 identifies a specific commercial package of 8 vial in 1 kit / 1 ml in 1 vial of Dihydroergotamine Mesylate Nasal, a human prescription drug labeled by Cipla Usa Inc.. 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 Cipla Usa Inc. on May 23, 2020. 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 Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097050327. 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)
69097-503-27
11-Digit CMS (5-4-2)
69097-0503-27

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