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  5. NDC Package Code: 65162-999-10 Fosphenytoin Sodium

NDC Package 65162-999-10 Fosphenytoin Sodium

Injection Intramuscular; Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65162-999-10
Package Description:
10 VIAL in 1 CARTON / 2 mL in 1 VIAL (65162-999-01)
Product Code:
65162-999
Proprietary Name:
Fosphenytoin Sodium
Non-Proprietary Name:
Fosphenytoin Sodium
Substance Name:
Fosphenytoin Sodium
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.
11-Digit NDC Billing Format:
65162099910
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • FOSPHENYTOIN SODIUM 50 mg/mL
    • Pharmacologic Class(es):
  • Anti-epileptic Agent - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 1A2 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2B6 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C8 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inducers - [MoA] (Mechanism of Action)
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078476
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-17-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 65162-999-10?

    The NDC Packaged Code 65162-999-10 is assigned to a package of 10 vial in 1 carton / 2 ml in 1 vial (65162-999-01) of Fosphenytoin Sodium, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 65162-999 included in the NDC Directory?

    Yes, Fosphenytoin Sodium with product code 65162-999 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on May 17, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65162-999-10?

    The 11-digit format is 65162099910. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265162-999-105-4-265162-0999-10