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  5. NDC Package Code: 76978-101-11 Atzumi

NDC Package 76978-101-11 Atzumi

Dihydroergotamine Mesylate Powder Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
76978-101-11
Package Description:
1 BOTTLE, UNIT-DOSE in 1 CARTON / 1 POWDER in 1 BOTTLE, UNIT-DOSE
Product Code:
76978-101
Proprietary Name:
Atzumi
Non-Proprietary Name:
Dihydroergotamine Mesylate
Substance Name:
Dihydroergotamine Mesylate
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.
11-Digit NDC Billing Format:
76978010111
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Satsuma Pharmaceuticals, Inc.
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route(s):
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s):
DIHYDROERGOTAMINE MESYLATE 5.2 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA217901
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
04-30-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
76978-101-088 BOTTLE, UNIT-DOSE in 1 CARTON / 1 POWDER in 1 BOTTLE, UNIT-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 76978-101-11?

The NDC Packaged Code 76978-101-11 is assigned to a package of 1 bottle, unit-dose in 1 carton / 1 powder in 1 bottle, unit-dose of Atzumi, a human prescription drug labeled by Satsuma Pharmaceuticals, Inc.. The product's dosage form is powder and is administered via nasal form.

Is NDC 76978-101 included in the NDC Directory?

Yes, Atzumi with product code 76978-101 is active and included in the NDC Directory. The product was first marketed by Satsuma Pharmaceuticals, Inc. on April 30, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 76978-101-11?

The 11-digit format is 76978010111. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-276978-101-115-4-276978-0101-11