Dilantin-125 Suspension
NDC Package 58151-115-35

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

Package Information

Dilantin-125 (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 Viatris Specialty Llc, this product is identified by NDC 58151-115 and is authorized under FDA application NDA008762.

Identification & Billing

NDC Package Code
58151-115-35
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 237 mL in 1 BOTTLE, PLASTIC
Product Code
58151-115
11-Digit Billing Format
58151011535
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dilantin-125
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
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA008762
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-19-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58151-115-35 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 237 ml in 1 bottle, plastic of Dilantin-125, a human prescription drug labeled by Viatris Specialty Llc. 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 Viatris Specialty Llc on April 19, 2024. 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 Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58151011535. 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 (5-3-2)
58151-115-35
11-Digit CMS (5-4-2)
58151-0115-35

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