1. Labeler Index
  2. Corium, Llc.
  3. NDC Product Code: 65038-561 Azstarys

NDC 65038-561 Azstarys

Serdexmethylphenidate And Dexmethylphenidate Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 65038-561?
    5. Azstarys 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:
65038-561
Proprietary Name:
Azstarys
Non-Proprietary Name: [1]
Serdexmethylphenidate And Dexmethylphenidate
Substance Name: [2]
Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride
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]
    Corium, Llc.
    Labeler Code:
    65038
    Product Label ID:
    00b5e716-5564-4bbd-acaf-df2bc45a5663
    FDA Application Number: [6]
    NDA212994
    DEA Schedule: [7]
    Schedule II (CII) Substances
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-16-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GRAY (C48324 - BODY)
    BLUE (C48333 - CAP)
    ORANGE (C48331 - CAP)
    Shape:
    CAPSULE (C48336)
    Size(s):
    16 MM
    Imprint(s):
    KP415;286
    KP415;429
    KP415;5612
    Score:
    1

    Product Packages

    NDC Code 65038-561-99

    Package Description: 100 CAPSULE in 1 BOTTLE, PLASTIC

    Price per Unit: $12.84808 per EA

    Product Details

    What is NDC 65038-561?

    The NDC code 65038-561 is assigned by the FDA to the product Azstarys which is a human prescription drug product labeled by Corium, Llc.. The generic name of Azstarys is serdexmethylphenidate and dexmethylphenidate. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 65038-561-99 100 capsule in 1 bottle, plastic . 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 Azstarys?

    AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

    What are Azstarys 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.

    Which are Azstarys UNII Codes?

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

    • SERDEXMETHYLPHENIDATE CHLORIDE (UNII: FN54BT298Y)
    • SERDEXMETHYLPHENIDATE (UNII: 0H8KZ470DW) (Active Moiety)
    • DEXMETHYLPHENIDATE HYDROCHLORIDE (UNII: 1678OK0E08)
    • DEXMETHYLPHENIDATE (UNII: M32RH9MFGP) (Active Moiety)

    Which are Azstarys 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 Azstarys?

    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: 2562186 - Azstarys 5.2 MG / 26.1 MG Oral Capsule
    • RxCUI: 2562186 - dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule [Azstarys]
    • RxCUI: 2562186 - Azstarys (dexmethylphenidate 5.2 MG (as dexmethylphenidate hydrochloride 6 MG) / serdexmethylphenidate 26.1 MG (as serdexmethylphenidate chloride 28 MG)) Oral Capsule
    • RxCUI: 2562187 - dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule
    • RxCUI: 2562187 - dexmethylphenidate 5.2 MG (as dexmethylphenidate hydrochloride 6 MG) / serdexmethylphenidate 26.1 MG (as serdexmethylphenidate chloride 28 MG) Oral Capsule

    Which are the Pharmacologic Classes for Azstarys?

    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

    Serdexmethylphenidate and Dexmethylphenidate


    The combination of serdexmethylphenidate and 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 6 years of age and older. The combination of serdexmethylphenidate and dexmethylphenidate is in a class of medications called central nervous system stimulants. These medications work by changing 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".