Zolmitriptan Tablet, Orally Disintegrating
NDC Package 65841-768-01

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

Zolmitriptan tablets is zolmitriptan is used to treat migraines. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-768 and is authorized under FDA application ANDA202890.

Identification & Billing

NDC Package Code
65841-768-01
Package Description
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
65841-768
11-Digit Billing Format
65841076801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zolmitriptan
Non-Proprietary Name
Zolmitriptan
Substance Name
Zolmitriptan
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZOLMITRIPTAN 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
Zydus Lifesciences Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA202890
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-16-2013
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 (65841-768). Click a package code to view its specific billing and regulatory data.

65841-768-06
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
65841-768-10
1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
65841-768-16
90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
65841-768-77
10 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-768-30)
65841-768-82
1 BLISTER PACK in 1 CARTON / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-768-87)

* 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 65841-768-01 identifies a specific commercial package of 100 tablet, orally disintegrating in 1 bottle of Zolmitriptan, a human prescription drug labeled by Zydus Lifesciences Limited. This tablet, orally disintegrating is formulated for oral 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 Zydus Lifesciences Limited on May 16, 2013. The current certification is valid through December 31, 2026.

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 Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841076801. 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)
65841-768-01
11-Digit CMS (5-4-2)
65841-0768-01

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