Rizatriptan Benzoate
NDC Package 72189-126-18

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 discontinued by the firm.

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. Marketed by Direct Rx, this product is identified by NDC 72189-126 and is authorized under FDA application ANDA203252.

Identification & Billing

NDC Package Code
72189-126-18
Package Description
18 TABLET in 1 BLISTER PACK
Product Code
72189-126
11-Digit Billing Format
72189012618
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. Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.’s Rizatriptan Benzoate 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 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, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablet is 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
Direct Rx
FDA Application #
ANDA203252
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-11-2020
End Marketing Date
11-20-2021
Listing Expiration
11-20-2021
Exclude Flag
D
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72189-126-18 identifies a specific commercial package of 18 tablet in 1 blister pack of Rizatriptan Benzoate, labeled by Direct Rx. 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 Direct Rx on November 11, 2020. The current certification is valid through November 20, 2021.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189012618. 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)
72189-126-18
11-Digit CMS (5-4-2)
72189-0126-18

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