Rizatriptan Benzoate
NDC Package 54868-6397-1

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Rizatriptan Benzoate is orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Orally Disintegrating Tablets. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6397 and is authorized under FDA application ANDA078173.

Identification & Billing

NDC Package Code
54868-6397-1
Package Description
9 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC
Product Code
54868-6397
11-Digit Billing Format
54868639701
RxNorm Crosswalk
  • RxCUI: 312837 - rizatriptan benzoate 10 MG Disintegrating Oral Tablet
  • RxCUI: 312837 - rizatriptan 10 MG Disintegrating Oral Tablet
  • RxCUI: 312837 - rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral Tablet

Clinical Specifications

Proprietary Name
Rizatriptan Benzoate
Dosage Form
-
Usage Information
Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Orally Disintegrating Tablets. However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information.Limitations of Use: Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks. Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA078173
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-29-2013
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-6397-1 identifies a specific commercial package of 9 tablet, orally disintegrating in 1 bottle, plastic of Rizatriptan Benzoate, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on January 29, 2013. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868639701. 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)
54868-6397-1
11-Digit CMS (5-4-2)
54868-6397-01

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