Zolmitriptan Tablet, Film Coated
NDC Package 71626-101-06

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

Package Information

Zolmitriptan tablets is zolmitriptan is used to treat migraines. This formulation utilizes a tablet, film coated delivery system. Marketed by Medstone Pharma Llc, this product is identified by NDC 71626-101 and is authorized under FDA application ANDA207867.

Identification & Billing

NDC Package Code
71626-101-06
Package Description
6 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
71626-101
11-Digit Billing Format
71626010106
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
Zolmitriptan
Non-Proprietary Name
Zolmitriptan
Substance Name
Zolmitriptan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
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
Medstone Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207867
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-30-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71626-101-06 identifies a specific commercial package of 6 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Zolmitriptan, a human prescription drug labeled by Medstone Pharma Llc. This tablet, film coated 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 Medstone Pharma Llc on May 30, 2018. 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 Medstone Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71626010106. 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)
71626-101-06
11-Digit CMS (5-4-2)
71626-0101-06

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