1. Home
  2. Labeler Index
  3. Harrow Eye, Llc
  4. 82667-200
  5. NDC Package Code: 82667-200-01 Iopidine 1%

NDC Package 82667-200-01 Iopidine 1%

Apraclonidine Hydrochloride Ophthalmic Solution Solution/ Drops Ophthalmic - 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:
82667-200-01
Package Description:
12 POUCH in 1 CARTON / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code:
82667-200
Proprietary Name:
Iopidine 1%
Non-Proprietary Name:
Apraclonidine Hydrochloride Ophthalmic Solution
Substance Name:
Apraclonidine Hydrochloride
Usage Information:
IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.
11-Digit NDC Billing Format:
82667020001
NDC to RxNorm Crosswalk:
  • RxCUI: 211020 - IOPIDINE 1 % Ophthalmic Solution
  • RxCUI: 211020 - apraclonidine 10 MG/ML Ophthalmic Solution [Iopidine]
  • RxCUI: 211020 - Iopidine 1 % Ophthalmic Solution
  • RxCUI: 211020 - Iopidine 10 MG/ML (apraclonidine hydrochloride 11.5 MG/ML) Ophthalmic Solution
  • RxCUI: 211020 - Iopidine 10 MG/ML Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Harrow Eye, Llc
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • APRACLONIDINE HYDROCHLORIDE 10 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA019779
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-01-2023
    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 82667-200-01?

    The NDC Packaged Code 82667-200-01 is assigned to a package of 12 pouch in 1 carton / 2 vial, single-dose in 1 pouch / .1 ml in 1 vial, single-dose of Iopidine 1%, a human prescription drug labeled by Harrow Eye, Llc. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 82667-200 included in the NDC Directory?

    Yes, Iopidine 1% with product code 82667-200 is active and included in the NDC Directory. The product was first marketed by Harrow Eye, Llc on August 01, 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 82667-200-01?

    The 11-digit format is 82667020001. 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
    5-3-282667-200-015-4-282667-0200-01