Fosphenytoin Injection, Solution
NDC Package 63323-403-09

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

Fosphenytoin (fosphenytoin sodium) injection is fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-403 and is authorized under FDA application ANDA078052.

Identification & Billing

NDC Package Code
63323-403-09
Package Description
25 VIAL in 1 TRAY / 2 mL in 1 VIAL
Product Code
63323-403
11-Digit Billing Format
63323040309
RxNorm Crosswalk
  • RxCUI: 1670195 - fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML Injection
  • RxCUI: 1670195 - 10 ML fosphenytoin sodium 75 MG/ML Injection
  • RxCUI: 1670195 - fosphenytoin sodium 500 MG PE per 10 ML Injection
  • RxCUI: 1670195 - fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) Injection
  • RxCUI: 1670200 - fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML Injection

Clinical Specifications

Proprietary Name
Fosphenytoin
Non-Proprietary Name
Fosphenytoin Sodium
Substance Name
Fosphenytoin Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FOSPHENYTOIN SODIUM 50 mg/mL
Pharmacologic Class
Usage Information
Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078052
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-14-2009
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 (63323-403). Click a package code to view its specific billing and regulatory data.

63323-403-02
25 VIAL in 1 TRAY / 2 mL in 1 VIAL (63323-403-01)
63323-403-10
10 VIAL in 1 TRAY / 10 mL in 1 VIAL (63323-403-04)

* 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 63323-403-09 identifies a specific commercial package of 25 vial in 1 tray / 2 ml in 1 vial of Fosphenytoin, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for intramuscular; intravenous use and contains fosphenytoin sodium 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 Fresenius Kabi Usa, Llc on December 14, 2009. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323040309. 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)
63323-403-09
11-Digit CMS (5-4-2)
63323-0403-09

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