Phenytoin Tablet, Chewable
NDC Package 70518-0841-3

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

Phenytoin tablets is phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). This formulation utilizes a tablet, chewable delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-0841 and is authorized under FDA application ANDA200565.

Identification & Billing

NDC Package Code
70518-0841-3
Package Description
50 POUCH in 1 BOX / 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2)
Product Code
70518-0841
11-Digit Billing Format
70518084103
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Phenytoin
Non-Proprietary Name
Phenytoin
Substance Name
Phenytoin
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PHENYTOIN 50 mg/1
Pharmacologic Class
Usage Information
Phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). It works by reducing the spread of seizure activity in the brain.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200565
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-10-2017
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70518-0841). Click a package code to view its specific billing and regulatory data.

70518-0841-0
30 TABLET, CHEWABLE in 1 BLISTER PACK
70518-0841-1
100 POUCH in 1 BOX / 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2)

* 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 70518-0841-3 identifies a specific commercial package of 50 pouch in 1 box / 1 tablet, chewable in 1 pouch (70518-0841-2) of Phenytoin, a human prescription drug labeled by Remedyrepack Inc.. This tablet, chewable is formulated for oral use and contains phenytoin 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 Remedyrepack Inc. on November 10, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). It works by reducing the spread of seizure activity in the brain.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518084103. 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)
70518-0841-3
11-Digit CMS (5-4-2)
70518-0841-03

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