1. Labeler Index
  2. Parke-davis Div Of Pfizer Inc
  3. NDC Product Code: 0071-0369 Dilantin

NDC 0071-0369 Dilantin

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

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0071-0369?
    5. Dilantin Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Pharmacologic Classes
    11. Patient Education

Product Information

NDC Product Code:
0071-0369
Proprietary Name:
Dilantin
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 - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Parke-davis Div Of Pfizer Inc
    Labeler Code:
    0071
    Product Label ID:
    8848de76-8d74-4620-bcc7-a86a596e5dd9
    FDA Application Number: [6]
    ANDA084349
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-27-1976
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - OPAQUE)
    PINK (C48328 - PALE PINK OPAQUE)
    ORANGE (C48331 - MEDIUM ORANGE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    14 MM
    16 MM
    Imprint(s):
    PD;DILANTIN;30;MG
    PD;DILANTIN;100;MG
    Score:
    1

    Product Packages

    NDC Code 0071-0369-24

    Package Description: 100 CAPSULE in 1 BOTTLE

    Price per Unit: $1.53698 per EA

    NDC Code 0071-0369-32

    Package Description: 1000 CAPSULE in 1 BOTTLE

    Price per Unit: $1.53698 per EA

    NDC Code 0071-0369-40

    Package Description: 100 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK

    Price per Unit: $1.53698 per EA

    Product Details

    What is NDC 0071-0369?

    The NDC code 0071-0369 is assigned by the FDA to the product Dilantin which is a human prescription drug product labeled by Parke-davis Div Of Pfizer Inc. The generic name of Dilantin is extended phenytoin sodium. The product's dosage form is capsule and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0071-0369-24 100 capsule in 1 bottle , 0071-0369-32 1000 capsule in 1 bottle , 0071-0369-40 100 blister pack in 1 carton / 1 capsule in 1 blister pack. 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 Dilantin?

    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 Dilantin 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 100 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 Dilantin UNII Codes?

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

    Which are Dilantin 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 Dilantin?

    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: 855671 - phenytoin sodium 100 MG Extended Release Oral Capsule
    • RxCUI: 855671 - DPH sodium 100 MG Extended Release Oral Capsule
    • RxCUI: 855673 - Dilantin 100 MG Extended Release Oral Capsule
    • RxCUI: 855673 - phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]
    • RxCUI: 855673 - DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]

    Which are the Pharmacologic Classes for Dilantin?

    * 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".