Sumatriptan And Naproxen Sodium Tablet, Film Coated
NDC Package 16714-891-01

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

Package Information

Sumatriptan And Naproxen Sodium tablets is sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults.Limitations of Use:Use only if a clear diagnosis of migraine headache has been established. This formulation utilizes a tablet, film coated delivery system. Marketed by Northstar Rxllc, this product is identified by NDC 16714-891 and is authorized under FDA application ANDA202803.

Identification & Billing

NDC Package Code
16714-891-01
Package Description
9 TABLET, FILM COATED in 1 BOTTLE
Product Code
16714-891
11-Digit Billing Format
16714089101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
9 EA
RxNorm Crosswalk
  • RxCUI: 849450 - SUMAtriptan 85 MG / naproxen sodium 500 MG Oral Tablet
  • RxCUI: 849450 - naproxen sodium 500 MG / sumatriptan 85 MG Oral Tablet
  • RxCUI: 849450 - naproxen sodium 500 MG / sumatriptan (as sumatriptan succinate) 85 MG Oral Tablet

Clinical Specifications

Proprietary Name
Sumatriptan And Naproxen Sodium
Non-Proprietary Name
Sumatriptan And Naproxen Sodium
Substance Name
Naproxen Sodium; 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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults.Limitations of Use:Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets  are administered to treat any subsequent attacks.Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks.Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.Pediatric use information for patients ages 12 to 17 years is approved for Pernix Ireland Ltd.’s TREXIMET® (sumatriptan and naproxen sodium) Tablets. However, due to Pernix Ireland Ltd.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Regulatory & Marketing

Labeler Name
Northstar Rxllc
Product Type
Human Prescription Drug
FDA Application #
ANDA202803
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-27-2018
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 16714-891-01 identifies a specific commercial package of 9 tablet, film coated in 1 bottle of Sumatriptan And Naproxen Sodium, a human prescription drug labeled by Northstar Rxllc. This tablet, film coated is formulated for oral use and contains naproxen sodium; 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 Northstar Rxllc on November 27, 2018. The current certification is valid through December 31, 2026.

How is this Northstar Rxllc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16714089101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 9 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)
16714-891-01
11-Digit CMS (5-4-2)
16714-0891-01

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