Rizatriptan Benzoate Odt Tablet, Orally Disintegrating
NDC Package 72189-341-09

11-digit billing NDC: 72189034109 · Billing unit: EA · 9 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Rizatriptan Benzoate Odt tablets is 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. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Direct Rx, this product is identified by NDC 72189-341 and is authorized under FDA application ANDA203062.

Identification & Billing

NDC Package Code
72189-341-09
Package Description
9 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
72189-341
11-Digit Billing Format
72189034109
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
9 EA
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 Odt
Non-Proprietary Name
Rizatriptan Benzoate Odt
Substance Name
Rizatriptan Benzoate
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RIZATRIPTAN BENZOATE 10 mg/1
Pharmacologic Class
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. 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
Direct Rx
Product Type
Human Prescription Drug
FDA Application #
ANDA203062
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-28-2022
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 72189-341-09 identifies a specific commercial package of 9 tablet, orally disintegrating in 1 bottle of Rizatriptan Benzoate Odt, a human prescription drug labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 9 billable units per package. This tablet, orally disintegrating is formulated for oral use and contains rizatriptan benzoate 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 Direct Rx on March 28, 2022. The current certification is valid through December 31, 2026.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189034109. 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 (5-3-2)
72189-341-09
11-Digit CMS (5-4-2)
72189-0341-09

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