Fosphenytoin Sodium Injection, Solution
NDC Package 68083-461-10

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 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 Gland Pharma Limited, this product is identified by NDC 68083-461 and is authorized under FDA application ANDA214926.

Identification & Billing

NDC Package Code
68083-461-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01)
Product Code
68083-461
11-Digit Billing Format
68083046110
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, 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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA214926
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-13-2023
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 68083-461-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (68083-461-01) of Fosphenytoin Sodium, a human prescription drug labeled by Gland Pharma Limited. 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 Gland Pharma Limited on October 13, 2023. The current certification is valid through December 31, 2026.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083046110. 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)
68083-461-10
11-Digit CMS (5-4-2)
68083-0461-10

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