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NDC 0187-5205 Benzamycin

Erythromycin And Benzoyl Peroxide Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0187-5205?
  4. Benzamycin Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

NDC Product Code:
0187-5205
Proprietary Name:
Benzamycin
Non-Proprietary Name: [1]
Erythromycin And Benzoyl Peroxide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Bausch Health Us, Llc
Labeler Code:
0187
Product Label ID:
c8c05e98-ec28-4636-8e5c-9a2557483e3c
FDA Application Number: [6]
NDA050557
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-26-1984
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Packages

NDC Code 0187-5205-46

Package Description: 1 KIT in 1 BOX * 1.6 g in 1 VIAL, PLASTIC * 40 g in 1 JAR

Price per Unit: $9.33596 per GM

Product Details

What is NDC 0187-5205?

The NDC code 0187-5205 is assigned by the FDA to the product Benzamycin which is a human prescription drug product labeled by Bausch Health Us, Llc. The generic name of Benzamycin is erythromycin and benzoyl peroxide. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0187-5205-46 1 kit in 1 box * 1.6 g in 1 vial, plastic * 40 g in 1 jar. 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 Benzamycin?

This product is used to treat moderate acne. It helps to reduce the number of pimples. This medication is a combination of 2 drugs. Erythromycin works by stopping the growth of acne-causing bacteria. It belongs to a class of drugs known as macrolide antibiotics. Benzoyl peroxide also kills acne-causing bacteria and causes the top layer of skin to dry and peel off so that new skin can form. This product also contains alcohol which helps to dry extra oils from the skin.

Which are Benzamycin UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Benzamycin Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Benzamycin?

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: 213082 - Benzamycin 3 % / 5 % Topical Gel
  • RxCUI: 213082 - benzoyl peroxide 0.05 MG/MG / erythromycin 0.03 MG/MG Topical Gel [Benzamycin]
  • RxCUI: 213082 - Benzamycin (benzoyl peroxide 5 % / erythromycin 3 % ) Topical Gel
  • RxCUI: 213082 - Benzamycin (benzoyl peroxide 50 MG / erythromycin 30 MG) per GM Topical Gel
  • RxCUI: 244374 - erythromycin 3 % / benzoyl peroxide 5 % Topical Gel

* Please review the disclaimer below.

Patient Education

Erythromycin and Benzoyl Peroxide Topical


The combination of erythromycin and benzoyl peroxide is used to treat acne. Erythromycin and benzoyl peroxide are in a class of medications called topical antibiotics. The combination of erythromycin 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.

[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.

[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".