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  5. NDC Package Code: 0404-9933-05 Phenytoin Sodium

NDC Package 0404-9933-05 Phenytoin 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:
0404-9933-05
Package Description:
1 VIAL, SINGLE-DOSE in 1 BAG / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
0404-9933
Proprietary Name:
Phenytoin Sodium
Non-Proprietary Name:
Phenytoin Sodium
Substance Name:
Phenytoin Sodium
Usage Information:
Parenteral Phenytoing Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. Parenteral phenytoind should be used only when oral phenytoin administration is not possible [see DOSAGE AND ADMINISTRATIONand WARNINGS AND PRECAUTIONS.
11-Digit NDC Billing Format:
00404993305
NDC to RxNorm Crosswalk:
  • RxCUI: 1670353 - phenytoin sodium 250 MG in 5 ML Injection
  • RxCUI: 1670353 - 5 ML phenytoin sodium 50 MG/ML Injection
  • RxCUI: 1670353 - 5 ML DPH sodium 50 MG/ML Injection
  • RxCUI: 1670353 - phenytoin sodium 250 MG per 5 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Henry Schein, Inc.
    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):
  • PHENYTOIN SODIUM 250 mg/5mL
    • 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:
    ANDA084307
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-13-2022
    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 0404-9933-05?

    The NDC Packaged Code 0404-9933-05 is assigned to a package of 1 vial, single-dose in 1 bag / 5 ml in 1 vial, single-dose of Phenytoin Sodium, a human prescription drug labeled by Henry Schein, Inc.. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 0404-9933 included in the NDC Directory?

    Yes, Phenytoin Sodium with product code 0404-9933 is active and included in the NDC Directory. The product was first marketed by Henry Schein, Inc. on January 13, 2022 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 0404-9933-05?

    The 11-digit format is 00404993305. 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 4-4-2 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
    4-4-20404-9933-055-4-200404-9933-05