Rizatriptan Benzoate
NDC Package 63629-8256-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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, USP are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Limitations of Use Rizatriptan benzoate orally disintegrating tablets, USP should only be used where a clear diagnosis of migraine has been established. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-8256 and is authorized under FDA application ANDA204722.

Identification & Billing

NDC Package Code
63629-8256-2
Package Description
18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
63629-8256
11-Digit Billing Format
63629825602
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, USP are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Limitations of Use Rizatriptan benzoate orally disintegrating tablets, USP 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, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks.Rizatriptan benzoate orally disintegrating tablets, USP are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].Rizatriptan benzoate orally disintegrating tablets, USP are not indicated for the prevention of migraine attacks.Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets, USP have not been established for cluster headache.

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
FDA Application #
ANDA204722
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-17-2017
Listing Expiration
12-31-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63629-8256). Click a package code to view its specific billing and regulatory data.

63629-8256-1
10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

* 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 63629-8256-2 identifies a specific commercial package of 18 tablet, orally disintegrating in 1 bottle of Rizatriptan Benzoate, labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on January 17, 2017. The current certification is valid through December 31, 2023.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629825602. 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)
63629-8256-2
11-Digit CMS (5-4-2)
63629-8256-02

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