Phenytoin Powder
NDC Package 0009-0488-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Phenytoin powders is phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). This formulation utilizes a powder delivery system. Marketed by Pharmacia And Upjohn Company Llc, this product is identified by NDC 0009-0488.

Identification & Billing

NDC Package Code
0009-0488-01
Package Description
1 BAG in 1 DRUM / 50 kg in 1 BAG
Product Code
0009-0488
11-Digit Billing Format
00009048801

Clinical Specifications

Proprietary Name
Phenytoin
Non-Proprietary Name
Phenytoin
Substance Name
Phenytoin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
PHENYTOIN 1 kg/kg
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
Pharmacia And Upjohn Company Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-13-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 0009-0488-01 identifies a specific commercial package of 1 bag in 1 drum / 50 kg in 1 bag of Phenytoin (UNFINISHED drug), a bulk ingredient labeled by Pharmacia And Upjohn Company Llc. This powder is formulated for 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 Pharmacia And Upjohn Company Llc on December 13, 2013. 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 Pharmacia And Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009048801. 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)
0009-0488-01
11-Digit CMS (5-4-2)
00009-0488-01

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