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  5. NDC Package Code: 42192-614-30 Phenytoin Sodium

NDC Package 42192-614-30 Phenytoin Sodium

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
42192-614-30
Package Description:
10 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code:
42192-614
Proprietary Name:
Phenytoin Sodium
Non-Proprietary Name:
Phenytoin Sodium
Substance Name:
Phenytoin Sodium
Usage Information:
Parenteral Phenytoin Sodium Injection, USP is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous Phenytoin Sodium Injection, USP can also be substituted, as short-term use, for oral phenytoin. Parenteral Phenytoin Sodium Injection, USP should be used only when oral phenytoin sodium injection administration is not possible [ see Dosage and Administration (2.1, 2.3) and Warnings and Precautions (5.1)].
11-Digit NDC Billing Format:
42192061430
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1670351 - phenytoin sodium 100 MG in 2 ML Injection
  • RxCUI: 1670351 - 2 ML phenytoin sodium 50 MG/ML Injection
  • RxCUI: 1670351 - 2 ML DPH sodium 50 MG/ML Injection
  • RxCUI: 1670351 - phenytoin sodium 100 MG per 2 ML Injection
  • RxCUI: 1670353 - phenytoin sodium 250 MG in 5 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Acella 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):
  • PHENYTOIN 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:
    ANDA040573
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-01-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    42192-614-1010 VIAL in 1 CARTON / 2 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42192-614-30?

    The NDC Packaged Code 42192-614-30 is assigned to a package of 10 vial in 1 carton / 5 ml in 1 vial of Phenytoin Sodium, a human prescription drug labeled by Acella Pharmaceuticals, Llc. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 42192-614 included in the NDC Directory?

    Yes, Phenytoin Sodium with product code 42192-614 is active and included in the NDC Directory. The product was first marketed by Acella Pharmaceuticals, Llc on December 01, 2021 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 NDC billing unit for package 42192-614-30?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 42192-614-30?

    The 11-digit format is 42192061430. 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
    5-3-242192-614-305-4-242192-0614-30