Phenytoin
NDC Package 16590-815-90

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-815 and is authorized under FDA application ANDA040298.

Identification & Billing

NDC Package Code
16590-815-90
Package Description
90 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
16590-815
11-Digit Billing Format
16590081590
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 ER
Dosage Form
-
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
Stat Rx Usa Llc
FDA Application #
ANDA040298
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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 (16590-815). Click a package code to view its specific billing and regulatory data.

16590-815-30
30 CAPSULE in 1 BOTTLE, PLASTIC
16590-815-60
60 CAPSULE in 1 BOTTLE, PLASTIC
16590-815-82
180 CAPSULE 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 16590-815-90 identifies a specific commercial package of 90 capsule in 1 bottle, plastic of Phenytoin ER, labeled by Stat Rx Usa Llc. 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 Stat Rx Usa Llc on November 20, 2009. The current certification is valid through December 31, 2017.

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 Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590081590. 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)
16590-815-90
11-Digit CMS (5-4-2)
16590-0815-90

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