Phenytoin Suspension
NDC Package 51672-4069-2

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 suspension is phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). This formulation utilizes a suspension delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-4069 and is authorized under FDA application ANDA040521.

Identification & Billing

NDC Package Code
51672-4069-2
Package Description
1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE
Product Code
51672-4069
11-Digit Billing Format
51672406902
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Phenytoin
Non-Proprietary Name
Phenytoin
Substance Name
Phenytoin
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PHENYTOIN 125 mg/5mL
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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040521
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-08-2004
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51672-4069). Click a package code to view its specific billing and regulatory data.

51672-4069-1
237 mL in 1 BOTTLE

* 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 51672-4069-2 identifies a specific commercial package of 1 bottle in 1 carton / 237 ml in 1 bottle of Phenytoin, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This suspension 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 Sun Pharmaceutical Industries, Inc. on April 08, 2004. The current certification is valid through December 31, 2026.

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 Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672406902. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
51672-4069-2
11-Digit CMS (5-4-2)
51672-4069-02

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