Rizatriptan Benzoate
NDC Package 53002-3713-1

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 tablets 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 UseRizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-3713 and is authorized under FDA application ANDA203269.

Identification & Billing

NDC Package Code
53002-3713-1
Package Description
3 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
Product Code
53002-3713
11-Digit Billing Format
53002371301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rizatriptan Benzoate
Dosage Form
-
Usage Information
Rizatriptan benzoate tablets 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 UseRizatriptan benzoate 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 tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.Rizatriptan benzoate tablets are not  indicated  for  use  in  the  management  of  hemiplegic  or  basilar  migraine  [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA203269
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-25-2012
Listing Expiration
12-31-2024
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 53002-3713-1 identifies a specific commercial package of 3 blister pack in 1 carton / 6 tablet in 1 blister pack of Rizatriptan Benzoate, labeled by Rpk Pharmaceuticals, 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 Rpk Pharmaceuticals, Inc. on June 25, 2012. The current certification is valid through December 31, 2024.

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002371301. 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)
53002-3713-1
11-Digit CMS (5-4-2)
53002-3713-01

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