NDC 0078-0608 Focalin XR

Dexmethylphenidate Hydrochloride Capsule, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-0608
Proprietary Name:
Focalin XR
Non-Proprietary Name: [1]
Dexmethylphenidate Hydrochloride
Substance Name: [2]
Dexmethylphenidate Hydrochloride
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 Code:
    0078
    FDA Application Number: [6]
    NDA021802
    DEA Schedule: [7]
    Schedule II (CII) Substances
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-31-2005
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    BROWN (C48332)
    WHITE (C48325)
    BLUE (C48333 - LIGHT BLUE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    19 MM
    Imprint(s):
    NVR;D30
    NVR;D25
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 0078-0608?

    The NDC code 0078-0608 is assigned by the FDA to the product Focalin XR which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Focalin XR is dexmethylphenidate hydrochloride. The product's dosage form is capsule, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 0078-0608-05 100 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 Focalin XR?

    This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Dexmethylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

    What are Focalin XR 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.
    • DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 - A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

    Which are Focalin XR UNII Codes?

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

    • DEXMETHYLPHENIDATE HYDROCHLORIDE (UNII: 1678OK0E08)
    • DEXMETHYLPHENIDATE (UNII: M32RH9MFGP) (Active Moiety)

    Which are Focalin XR 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 Focalin XR?

    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: 1006608 - dexmethylphenidate HCl 40 MG 24HR Extended Release Oral Capsule
    • RxCUI: 1006608 - 24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule
    • RxCUI: 1006608 - dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral Capsule
    • RxCUI: 1006610 - Focalin XR 40 MG 24HR Extended Release Oral Capsule
    • RxCUI: 1006610 - 24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Focalin]

    Which are the Pharmacologic Classes for Focalin XR?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Dexmethylphenidate


    Dexmethylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Dexmethylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by increasing the amounts of certain natural substances 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.

    [7] What is the Drug Enforcement Administration (DEA) CII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

    [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".