Sumatriptan Succinate Tablet, Film Coated
NDC Package 57315-216-02

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.

Sumatriptan Succinate tablets is sumatriptan is used to treat migraines and cluster headaches. This formulation utilizes a tablet, film coated delivery system. Marketed by Alphapharm Pty Ltd, this product is identified by NDC 57315-216.

Identification & Billing

NDC Package Code
57315-216-02
Package Description
500000 TABLET, FILM COATED in 1 DRUM
Product Code
57315-216
11-Digit Billing Format
57315021602

Clinical Specifications

Proprietary Name
Sumatriptan Succinate
Non-Proprietary Name
Sumatriptan Succinate
Substance Name
Sumatriptan Succinate
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)
SUMATRIPTAN SUCCINATE 100 mg/1
Usage Information
Sumatriptan is used to treat migraines and cluster headaches. It helps to relieve pain and other symptoms of migraines/headaches including sensitivity to light or sound, nausea, and vomiting. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications. It does not prevent future migraines/headaches or reduce how often you may get a headache. Sumatriptan belongs to a group of drugs called triptans. It affects a certain natural chemical (serotonin) that constricts blood vessels in the brain. It may also block other pain pathways in the brain.

Regulatory & Marketing

Labeler Name
Alphapharm Pty Ltd
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-17-2020
Listing Expiration
12-31-2026
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 57315-216-02 identifies a specific commercial package of 500000 tablet, film coated in 1 drum of Sumatriptan Succinate (UNFINISHED drug), drug for further processing labeled by Alphapharm Pty Ltd. This tablet, film coated is formulated for use and contains sumatriptan succinate 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 Alphapharm Pty Ltd on September 17, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sumatriptan is used to treat migraines and cluster headaches. It helps to relieve pain and other symptoms of migraines/headaches including sensitivity to light or sound, nausea, and vomiting. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications. It does not prevent future migraines/headaches or reduce how often you may get a headache. Sumatriptan belongs to a group of drugs called triptans. It affects a certain natural chemical (serotonin) that constricts blood vessels in the brain. It may also block other pain pathways in the brain.

How is this Alphapharm Pty Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57315021602. 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)
57315-216-02
11-Digit CMS (5-4-2)
57315-0216-02

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