Dihydroergotamine Mesylate Spray
NDC Package 68682-357-10

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

Package Information

Dihydroergotamine Mesylate sprays is a medication used to treat migraine headache attacks. This formulation utilizes a spray delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-357 and is authorized under FDA application NDA020148.

Identification & Billing

NDC Package Code
68682-357-10
Package Description
8 VIAL in 1 KIT / 1 mL in 1 VIAL
Product Code
68682-357
11-Digit Billing Format
68682035710
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
Non-Proprietary Name
Dihydroergotamine Mesylate
Substance Name
Dihydroergotamine Mesylate
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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
This medication is used to treat migraine headache attacks. It helps relieve headache pain and other symptoms such as sensitivity to light or sound. Prompt treatment allows you to get back to your normal routine sooner and may decrease your need for other pain medications. This medication is not used to prevent migraines from occurring. Dihydroergotamine belongs to a class of drugs known as ergot alkaloids. It may work by narrowing the blood vessels in the brain. It may also block other pain pathways in the brain.

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA020148
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-18-2013
End Marketing Date
06-30-2027
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 68682-357-10 identifies a specific commercial package of 8 vial in 1 kit / 1 ml in 1 vial of Dihydroergotamine Mesylate, a human prescription drug labeled by Oceanside Pharmaceuticals. This spray 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 Oceanside Pharmaceuticals on March 18, 2013.

What are the primary indications for this medication?

This medication is used to treat migraine headache attacks. It helps relieve headache pain and other symptoms such as sensitivity to light or sound. Prompt treatment allows you to get back to your normal routine sooner and may decrease your need for other pain medications. This medication is not used to prevent migraines from occurring. Dihydroergotamine belongs to a class of drugs known as ergot alkaloids. It may work by narrowing the blood vessels in the brain. It may also block other pain pathways in the brain.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682035710. 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)
68682-357-10
11-Digit CMS (5-4-2)
68682-0357-10

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