Naratriptan Tablet
NDC Package 0054-0278-03

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

Package Information

Naratriptan tablets is naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. This formulation utilizes a tablet delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-0278 and is authorized under FDA application ANDA090381.

Identification & Billing

NDC Package Code
0054-0278-03
Package Description
9 TABLET in 1 BOTTLE
Product Code
0054-0278
11-Digit Billing Format
00054027803
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
9 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naratriptan
Non-Proprietary Name
Naratriptan
Substance Name
Naratriptan Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NARATRIPTAN HYDROCHLORIDE 1 mg/1
Pharmacologic Class
Usage Information
Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use:•Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks.•Naratriptan is not indicated for the prevention of migraine attacks.•Safety and effectiveness of naratriptan have not been established for cluster headache.

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090381
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-07-2010
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 0054-0278-03 identifies a specific commercial package of 9 tablet in 1 bottle of Naratriptan, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This tablet is formulated for oral use and contains naratriptan hydrochloride 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 Hikma Pharmaceuticals Usa Inc. on July 07, 2010. The current certification is valid through December 31, 2026.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054027803. 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 (4-4-2)
0054-0278-03
11-Digit CMS (5-4-2)
00054-0278-03

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