Zolmitriptan Tablet, Film Coated
NDC Package 63548-1010-0

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Zolmitriptan tablets is zolmitriptan is used to treat migraines. This formulation utilizes a tablet, film coated delivery system. Marketed by Pld Acquisitions Llc Dba Av�ma Pharma Solutions, this product is identified by NDC 63548-1010.

Identification & Billing

NDC Package Code
63548-1010-0
Package Description
349515 BLISTER PACK in 1 DRUM / 349515 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
63548-1010
11-Digit Billing Format
63548101000

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.
Active Ingredient(s)
ZOLMITRIPTAN 2.5 mg/1
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
Pld Acquisitions Llc Dba Av�ma Pharma Solutions
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
11-20-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 63548-1010-0 identifies a specific commercial package of 349515 blister pack in 1 drum / 349515 tablet, film coated in 1 blister pack of Zolmitriptan (UNFINISHED drug), a bulk ingredient labeled by Pld Acquisitions Llc Dba Av�ma Pharma Solutions. This tablet, film coated is formulated for 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 Pld Acquisitions Llc Dba Av�ma Pharma Solutions on November 20, 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 Pld Acquisitions Llc Dba Av�ma Pharma Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63548101000. 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 (5-4-1)
63548-1010-0
11-Digit CMS (5-4-2)
63548-1010-00

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