Dexmethylphenidate Hydrochloride
NDC 49884-090

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 49884-090?
  5. Dexmethylphenidate Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Dexmethylphenidate Hydrochloride is a ANDA-approved product labeled by Par Health Usa, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 49884-090 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
49884-090
Proprietary Name:
Dexmethylphenidate Hydrochloride
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Par Health Usa, Llc
Labeler Code:
49884
Product Label ID:
e304388e-86a6-4335-abae-0ce79c7c99c6
FDA Application Number: [6]
ANDA202842
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-05-2017
End Marketing Date: [10]
01-08-2025
Listing Expiration Date: [11]
01-08-2025
Exclude Flag: [12]
D

Product Characteristics

Color(s):
WHITE (C48325 - YELLOW)
BLUE (C48333 - LIGHT BLUE)
BROWN (C48332 - BEIGE)
GREEN (C48329 - GREEN)
Shape:
CAPSULE (C48336)
Size(s):
23 MM
18 MM
19 MM
Imprint(s):
PAR;546
PAR;048
PAR;049
PAR;090
Score:
1

Code Structure Chart

Product Details

What is NDC 49884-090?

The NDC code 49884-090 is assigned by the FDA to the product Dexmethylphenidate Hydrochloride. This pharmaceutical product is labeled by Par Health Usa, Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 49884-090-01. 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?

Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of dexmethylphenidate hydrochloride extended-release in the treatment of ADHD in patients aged 6 years and older was established in two placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [ see Clinical Studies (14)]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met.Special Diagnostic ConsiderationsSpecific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.Need for Comprehensive Treatment ProgramDexmethylphenidate hydrochloride extended-release is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.Long-Term UseThe effectiveness of dexmethylphenidate hydrochloride extended-release for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dexmethylphenidate hydrochloride extended-release for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].

Which are the associated UNII Codes?

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

  • 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: 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: 1101926 - dexmethylphenidate HCl 25 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1101926 - 24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule

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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]


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Product & Regulatory Definitions
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 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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".