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  5. NDC Package Code: 0187-3050-50 Onexton

NDC Package 0187-3050-50 Onexton

Clindamycin Phosphate And Benzoyl Peroxide Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0187-3050-50
Package Description:
1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP
Product Code:
0187-3050
Proprietary Name:
Onexton
Non-Proprietary Name:
Clindamycin Phosphate And Benzoyl Peroxide
Substance Name:
Benzoyl Peroxide; Clindamycin Phosphate
Usage Information:
This combination medication is used to treat a certain type of acne (inflammatory acne vulgaris). It helps to decrease the number of acne pimples. Clindamycin is an antibiotic that stops the growth of acne-causing bacteria. Benzoyl peroxide can also stop the growth of bacteria as well as reduce oil production in the skin, helping keep your pores open.
11-Digit NDC Billing Format:
00187305050
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
50 GM
Product Type:
Human Prescription Drug
Labeler Name:
Bausch Health Us, Llc
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):
  • BENZOYL PEROXIDE 37.5 mg/g
  • CLINDAMYCIN PHOSPHATE 10 mg/g
    • Pharmacologic Class(es):
  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Lincosamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Lincosamides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA050819
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-24-2014
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0187-3050-353.5 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0187-3050-50?

    The NDC Packaged Code 0187-3050-50 is assigned to a package of 1 bottle, pump in 1 carton / 50 g in 1 bottle, pump of Onexton, a human prescription drug labeled by Bausch Health Us, Llc. The product's dosage form is gel and is administered via topical form.

    Is NDC 0187-3050 included in the NDC Directory?

    Yes, Onexton with product code 0187-3050 is active and included in the NDC Directory. The product was first marketed by Bausch Health Us, Llc on November 24, 2014 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 0187-3050-50?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 50.

    What is the 11-digit format for NDC 0187-3050-50?

    The 11-digit format is 00187305050. 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
    4-4-20187-3050-505-4-200187-3050-50