Primidone Tablet
NDC Package 0591-5321-77

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

Primidone tablets is a medication used alone or with other medications to control seizures. This formulation utilizes a tablet delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-5321 and is authorized under FDA application ANDA083551.

Identification & Billing

NDC Package Code
0591-5321-77
Package Description
32004 TABLET in 1 CONTAINER
Product Code
0591-5321
11-Digit Billing Format
00591532177
RxNorm Crosswalk
RxCUI: 96304 - primidone 250 MG Oral Tablet

Clinical Specifications

Proprietary Name
Primidone
Non-Proprietary Name
Primidone
Substance Name
Primidone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is used alone or with other medications to control seizures. Controlling and reducing seizures lets you do more of your normal daily activities, reduces your risk of harm when you lose consciousness, and lessens your risk for a possibly life-threatening condition of frequent, repeated seizures. Primidone belongs to a class of drugs known as barbiturate anticonvulsants. It works by controlling the abnormal electrical activity in the brain that occurs during a seizure.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA083551
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-19-2010
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
N/A

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 (0591-5321). Click a package code to view its specific billing and regulatory data.

0591-5321-00
27000 TABLET in 1 BAG
0591-5321-01
100 TABLET in 1 BOTTLE, PLASTIC

* 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 0591-5321-77 identifies a specific commercial package of 32004 tablet in 1 container of Primidone, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet is formulated for oral use and contains primidone 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 Actavis Pharma, Inc. on June 19, 2010. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used alone or with other medications to control seizures. Controlling and reducing seizures lets you do more of your normal daily activities, reduces your risk of harm when you lose consciousness, and lessens your risk for a possibly life-threatening condition of frequent, repeated seizures. Primidone belongs to a class of drugs known as barbiturate anticonvulsants. It works by controlling the abnormal electrical activity in the brain that occurs during a seizure.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591532177. 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 (4-4-2)
0591-5321-77
11-Digit CMS (5-4-2)
00591-5321-77

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