NDC Package 0078-0608-05 Focalin XR

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

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:
0078-0608-05
Package Description:
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Focalin XR
Non-Proprietary Name:
Dexmethylphenidate Hydrochloride
Substance Name:
Dexmethylphenidate Hydrochloride
Usage Information:
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.
11-Digit NDC Billing Format:
00078060805
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • 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]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    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.
  • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA021802
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-31-2005
    Listing Expiration Date:
    12-31-2024
    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0608-05?

    The NDC Packaged Code 0078-0608-05 is assigned to a package of 100 capsule, extended release in 1 bottle of Focalin XR, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is capsule, extended release and is administered via oral form.

    Is NDC 0078-0608 included in the NDC Directory?

    Yes, Focalin XR with product code 0078-0608 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on May 31, 2005 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0078-0608-05?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 0078-0608-05?

    The 11-digit format is 00078060805. 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 4-4-2 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
    4-4-20078-0608-055-4-200078-0608-05