Azstarys Capsule
NDC 65038-561

View dosage, usage, ingredients, routes, and UNII mappings.
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

Azstarys (serdexmethylphenidate and dexmethylphenidate) is a NDA-approved product labeled by Commave Sub, Llc. This medication is typically used as a central nervous system stimulant [epc]. It is supplied as a gray capsule for oral administration. This product entry covers the primary NDC 65038-561 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Commave Sub, 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.

Marketing Timeline

Start Marketing Date: [9]
07-16-2021
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

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

Code Structure Chart

Product Details

What is NDC 65038-561?

The NDC code 65038-561 is assigned by the FDA to the product Azstarys. It is commonly known by its generic name, serdexmethylphenidate and dexmethylphenidate. This pharmaceutical product is labeled by Commave Sub, Llc and is currently categorized as listed product. The medication is a capsule administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 65038-561-99. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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

What are Active Ingredients of this product?

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 the associated 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 the Inactive Ingredients associated 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 this product?

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 of this product?

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.

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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]


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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the DEA Schedule? This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".