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  5. NDC Package Code: 49884-428-10 Dexmethylphenidate Hydrochloride Extended-release

NDC Package 49884-428-10 Dexmethylphenidate Hydrochloride Extended-release

Capsule, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
49884-428-10
Package Description:
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
49884-428
Proprietary Name:
Dexmethylphenidate Hydrochloride Extended-release
Non-Proprietary Name:
Dexmethylphenidate Hydrochloride
Substance Name:
Dexmethylphenidate Hydrochloride
Usage Information:
Dexmethylphenidate Hydrochloride Extended-release Capsules 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 Capsules 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 2 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 6 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 6 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 Capsules 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 Capsules 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 Capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Dosage And Administration (2 .3)].
11-Digit NDC Billing Format:
49884042810
NDC to RxNorm Crosswalk:
  • RxCUI: 899461 - dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule
  • RxCUI: 899461 - 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule
  • RxCUI: 899461 - dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 899495 - dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule
  • RxCUI: 899495 - 24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule
Product Type:
Human Prescription Drug
Labeler Name:
Par Pharmaceuticals, Inc.
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):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1
Pharmacologic Class(es):
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
ANDA078992
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
11-19-2013
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
49884-428-01100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

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Frequently Asked Questions

What is NDC 49884-428-10?

The NDC Packaged Code 49884-428-10 is assigned to a package of 1000 capsule, extended release in 1 bottle of Dexmethylphenidate Hydrochloride Extended-release, a human prescription drug labeled by Par Pharmaceuticals, Inc.. The product's dosage form is capsule, extended release and is administered via oral form.

Is NDC 49884-428 included in the NDC Directory?

Yes, Dexmethylphenidate Hydrochloride Extended-release with product code 49884-428 is active and included in the NDC Directory. The product was first marketed by Par Pharmaceuticals, Inc. on November 19, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 49884-428-10?

The 11-digit format is 49884042810. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-249884-428-105-4-249884-0428-10