Phenytoin Suspension
NDC Package 0121-0892-63

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0892 and is authorized under FDA application ANDA040521.

Identification & Billing

NDC Package Code
0121-0892-63
Package Description
4 mL in 1 CUP, UNIT-DOSE
Product Code
0121-0892
11-Digit Billing Format
00121089263
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
4 ML
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
Pai Holdings, Llc Dba Pai Pharma
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0121-0892-63 identifies a specific commercial package of 4 ml in 1 cup, unit-dose of Phenytoin, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. This product is billed per "ML" milliliter and contains an estimated amount of 4 billable units per package. 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 Pai Holdings, Llc Dba Pai Pharma 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 Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121089263. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 4 total billable units per package. 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 (4-4-2)
0121-0892-63
11-Digit CMS (5-4-2)
00121-0892-63

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