Fosphenytoin Sodium Injection
NDC Package 65162-998-25

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

Package Information

Fosphenytoin Sodium injection is uSP is indicated for the control of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. This formulation utilizes a injection delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-998 and is authorized under FDA application ANDA078476.

Identification & Billing

NDC Package Code
65162-998-25
Package Description
25 VIAL in 1 CARTON / 2 mL in 1 VIAL (65162-998-01)
Product Code
65162-998
11-Digit Billing Format
65162099825
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 Sodium
Non-Proprietary Name
Fosphenytoin Sodium
Substance Name
Fosphenytoin Sodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
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, USP is indicated for the control of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin can also be substituted, short-term, for oral phenytoin.  Fosphenytoin should be used only when oral phenytoin administration is not possible.  Fosphenytoin must not be given orally.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078476
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-17-2013
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 65162-998-25 identifies a specific commercial package of 25 vial in 1 carton / 2 ml in 1 vial (65162-998-01) of Fosphenytoin Sodium, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This injection 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 Amneal Pharmaceuticals Llc on May 17, 2013. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162099825. 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)
65162-998-25
11-Digit CMS (5-4-2)
65162-0998-25

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