Zomig Spray, Metered
NDC Package 64896-083-12

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

Package Information

Zomig (zolmitriptan) sprays is zolmitriptan is used to treat migraines. This formulation utilizes a spray, metered delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 64896-083 and is authorized under FDA application NDA021450.

Identification & Billing

NDC Package Code
64896-083-12
Package Description
6 BOTTLE, SPRAY in 1 CARTON / 1 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
64896-083
11-Digit Billing Format
64896008312
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zomig
Non-Proprietary Name
Zolmitriptan
Substance Name
Zolmitriptan
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)
ZOLMITRIPTAN 2.5 mg/1
Pharmacologic Class
Usage Information
Zolmitriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Zolmitriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain. Zolmitriptan does not prevent future migraines or lessen how often you get migraine attacks.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021450
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-15-2024
Listing Expiration
12-31-2027
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 64896-083-12 identifies a specific commercial package of 6 bottle, spray in 1 carton / 1 spray, metered in 1 bottle, spray of Zomig, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This spray, metered is formulated for nasal use and contains zolmitriptan 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 July 15, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Zolmitriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Zolmitriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain. Zolmitriptan does not prevent future migraines or lessen how often you get migraine attacks.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64896008312. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 total billable units per package. 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)
64896-083-12
11-Digit CMS (5-4-2)
64896-0083-12

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