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  5. NDC Package Code: 82160-126-01 Spotex

NDC Package 82160-126-01 Spotex

Erythromycin Gel Topical - 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:
82160-126-01
Package Description:
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code:
82160-126
Proprietary Name:
Spotex
Non-Proprietary Name:
Erythromycin
Substance Name:
Erythromycin
Usage Information:
Spotex is indicated for the treatment of Acne Vulgaris, Acne appears as blackheads and whiteheads which people often refer to as pimples or spots. Spotex attacks the bacteria that are one of the main causes of acne. The name of these bacteria is Propionibacterium acnes
11-Digit NDC Billing Format:
82160012601
NDC to RxNorm Crosswalk:
  • RxCUI: 250697 - erythromycin 4 % Topical Gel
  • RxCUI: 250697 - erythromycin 0.04 MG/MG Topical Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pella Pharmaceuticals Co. Ltd
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • ERYTHROMYCIN 1200 mg/30g
    • Pharmacologic Class(es):
  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Macrolide Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Macrolide - [EPC] (Established Pharmacologic Class)
  • Macrolides - [CS]
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    09-10-2013
    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 82160-126-01?

    The NDC Packaged Code 82160-126-01 is assigned to a package of 1 tube in 1 carton / 30 g in 1 tube of Spotex, a human prescription drug labeled by Pella Pharmaceuticals Co. Ltd. The product's dosage form is gel and is administered via topical form.

    Is NDC 82160-126 included in the NDC Directory?

    Yes, Spotex with product code 82160-126 is active and included in the NDC Directory. The product was first marketed by Pella Pharmaceuticals Co. Ltd on September 10, 2013 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 82160-126-01?

    The 11-digit format is 82160012601. 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
    5-3-282160-126-015-4-282160-0126-01