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  5. NDC Package Code: 82111-517-01 Dartisla Odt

NDC Package 82111-517-01 Dartisla Odt

Glycopyrrolate Orally Disintegrating Tablets Tablet, Orally Disintegrating Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
82111-517-01
Package Description:
3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code:
82111-517
Proprietary Name:
Dartisla Odt
Non-Proprietary Name:
Glycopyrrolate Orally Disintegrating Tablets
Substance Name:
Glycopyrrolate
Usage Information:
Glycopyrrolate solution is used to reduce excessive drooling caused by medical conditions (such as cerebral palsy). This medication works by decreasing the amount of saliva you make. Glycopyrrolate belongs to a class of drugs known as anticholinergics.
11-Digit NDC Billing Format:
82111051701
NDC to RxNorm Crosswalk:
  • RxCUI: 2589274 - glycopyrrolate 1.7 MG Disintegrating Oral Tablet
  • RxCUI: 2589281 - Dartisla ODT 1.7 MG Disintegrating Oral Tablet
  • RxCUI: 2589281 - glycopyrrolate 1.7 MG Disintegrating Oral Tablet [Dartisla]
  • RxCUI: 2589281 - Dartisla 1.7 MG Disintegrating Oral Tablet
  • RxCUI: 2668158 - glycopyrrolate 0.85 MG Disintegrating Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Edenbridge Pharmaceuticals Llc.
    Dosage Form:
    Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GLYCOPYRROLATE .85 mg/1
    • Pharmacologic Class(es):
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA215019
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-11-2023
    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 82111-517-01?

    The NDC Packaged Code 82111-517-01 is assigned to a package of 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack of Dartisla Odt, a human prescription drug labeled by Edenbridge Pharmaceuticals Llc.. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

    Is NDC 82111-517 included in the NDC Directory?

    Yes, Dartisla Odt with product code 82111-517 is active and included in the NDC Directory. The product was first marketed by Edenbridge Pharmaceuticals Llc. on October 11, 2023 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 11-digit format for NDC 82111-517-01?

    The 11-digit format is 82111051701. 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
    5-3-282111-517-015-4-282111-0517-01