NDC Package 70010-012-01 Methylphenidate 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:
70010-012-01
Package Description:
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Methylphenidate Hydrochloride
Non-Proprietary Name:
Methylphenidate Hydrochloride
Substance Name:
Methylphenidate Hydrochloride
Usage Information:
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)] .
11-Digit NDC Billing Format:
70010001201
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: 1806177 - methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral Capsule
  • RxCUI: 1806177 - 50/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule
  • RxCUI: 1806179 - methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral Capsule
  • RxCUI: 1806179 - 50/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule
  • RxCUI: 1806183 - methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Granules 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.
  • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA211796
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-10-2019
    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 70010-012-01?

    The NDC Packaged Code 70010-012-01 is assigned to a package of 100 capsule, extended release in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Granules Pharmaceuticals Inc.. The product's dosage form is capsule, extended release and is administered via oral form.

    Is NDC 70010-012 included in the NDC Directory?

    Yes, Methylphenidate Hydrochloride with product code 70010-012 is active and included in the NDC Directory. The product was first marketed by Granules Pharmaceuticals Inc. on September 10, 2019 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 70010-012-01?

    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 70010-012-01?

    The 11-digit format is 70010001201. 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
    5-3-270010-012-015-4-270010-0012-01