Phenytoin Sodium Capsule, Extended Release
NDC Package 70518-0107-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Phenytoin Sodium capsules is extended phenytoin sodium capsules, USP are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. This formulation utilizes a capsule, extended release delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-0107 and is authorized under FDA application ANDA040684.

Identification & Billing

NDC Package Code
70518-0107-0
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
70518-0107
11-Digit Billing Format
70518010700
RxNorm Crosswalk
  • RxCUI: 855671 - phenytoin sodium 100 MG Extended Release Oral Capsule
  • RxCUI: 855671 - DPH sodium 100 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Phenytoin Sodium
Non-Proprietary Name
Phenytoin Sodium
Substance Name
Phenytoin Sodium
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PHENYTOIN SODIUM 100 mg/1
Pharmacologic Class
Usage Information
Extended phenytoin sodium capsules, USP are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040684
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-06-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-0107-0 identifies a specific commercial package of 30 capsule, extended release in 1 blister pack of Phenytoin Sodium, a human prescription drug labeled by Remedyrepack Inc.. This capsule, extended release is formulated for oral use and contains phenytoin sodium 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 January 06, 2017. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518010700. 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)
70518-0107-0
11-Digit CMS (5-4-2)
70518-0107-00

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