NDC 0378-2670 Phenytek

Extended Phenytoin Sodium Capsule, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0378-2670
Proprietary Name:
Phenytek
Non-Proprietary Name: [1]
Extended Phenytoin Sodium
Substance Name: [2]
Phenytoin Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Mylan Pharmaceuticals Inc.
    Labeler Code:
    0378
    FDA Application Number: [6]
    ANDA040298
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    12-10-2001
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333 - DARK BLUE OPAQUE)
    BLUE (C48333 - BLUE OPAQUE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    18 MM
    Imprint(s):
    BERTEK;670
    Score:
    1

    Product Packages

    NDC Code 0378-2670-01

    Package Description: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $1.39672 per EA

    NDC Code 0378-2670-93

    Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $1.39672 per EA

    Product Details

    What is NDC 0378-2670?

    The NDC code 0378-2670 is assigned by the FDA to the product Phenytek which is a human prescription drug product labeled by Mylan Pharmaceuticals Inc.. The generic name of Phenytek is extended phenytoin sodium. The product's dosage form is capsule, extended release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0378-2670-01 100 capsule, extended release in 1 bottle , 0378-2670-93 30 capsule, extended release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Phenytek?

    Phenytoin is used to prevent and control seizures (also called an anticonvulsant or antiepileptic drug). It works by reducing the spread of seizure activity in the brain.

    What are Phenytek Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • PHENYTOIN SODIUM 200 mg/1 - An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs.

    Which are Phenytek UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Phenytek Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Phenytek?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 855861 - phenytoin sodium 200 MG Extended Release Oral Capsule
    • RxCUI: 855861 - DPH sodium 200 MG Extended Release Oral Capsule
    • RxCUI: 855863 - Phenytek 200 MG Extended Release Oral Capsule
    • RxCUI: 855863 - phenytoin sodium 200 MG Extended Release Oral Capsule [Phenytek]
    • RxCUI: 855863 - DPH sodium 200 MG Extended Release Oral Capsule [Phenytek]

    Which are the Pharmacologic Classes for Phenytek?

    * Please review the disclaimer below.

    Patient Education

    Phenytoin


    Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".