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  4. NDC Product Code: 68462-859 Clindamycin And Benzoyl Peroxide

NDC 68462-859 Clindamycin And Benzoyl Peroxide

Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 68462-859?
  4. Clindamycin And Benzoyl Peroxide Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Pharmacologic Classes
  8. Patient Education

Product Information

NDC Product Code:
68462-859
Proprietary Name:
Clindamycin And Benzoyl Peroxide
Non-Proprietary Name: [1]
Clindamycin And Benzoyl Peroxide
Substance Name: [2]
Benzoyl Peroxide; Clindamycin Phosphate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Glenmark Pharmaceuticals Inc., Usa
    Labeler Code:
    68462
    Product Label ID:
    76795d1b-e1f2-4d1d-b42a-f1d4448c63c0
    FDA Application Number: [6]
    ANDA209252
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-24-2021
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 68462-859?

    The NDC code 68462-859 is assigned by the FDA to the product Clindamycin And Benzoyl Peroxide which is a human prescription drug product labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is gel and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 68462-859-24 1 bottle, pump in 1 carton / 35 g in 1 bottle, pump, 68462-859-27 1 bottle, pump in 1 carton / 50 g in 1 bottle, pump. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Clindamycin And Benzoyl Peroxide?

    Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.

    What are Clindamycin And Benzoyl Peroxide Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    What is the NDC to RxNorm Crosswalk for Clindamycin And Benzoyl Peroxide?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 358917 - clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical Gel
    • RxCUI: 358917 - benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical Gel
    • RxCUI: 358917 - benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical Gel
    • RxCUI: 358917 - benzoyl peroxide 5 % / clindamycin 1 % Topical Gel

    Which are the Pharmacologic Classes for Clindamycin And Benzoyl Peroxide?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Clindamycin and Benzoyl Peroxide Topical


    The combination of clindamycin and benzoyl peroxide is used to treat acne. Clindamycin and benzoyl peroxide are in a class of medications called topical antibiotics. The combination of clindamycin and benzoyl peroxide works by killing the bacteria that cause acne.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".