NDC 0023-5206 Aczone 7.5
Dapsone Gel Topical

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0023-5206?
    4. Aczone 7.5 Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0023-5206
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Aczone 7.5
Non-Proprietary Name 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.		Dapsone
Substance Name 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.		Dapsone
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormGel - 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Allergan, Inc.
Labeler Code0023
SPL SET ID:e3426f2f-4d2b-40b4-ac26-e7d873c30f78
FDA Application Number 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.		NDA207154
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		02-26-2016
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 0023-5206-30

Package Description: 1 BOTTLE, PUMP in 1 CARTON / 30 g in 1 BOTTLE, PUMP

NDC Code 0023-5206-60

Package Description: 1 BOTTLE, PUMP in 1 CARTON / 60 g in 1 BOTTLE, PUMP

Price per Unit: $11.01196 per GM

NDC Code 0023-5206-90

Package Description: 1 BOTTLE, PUMP in 1 CARTON / 90 g in 1 BOTTLE, PUMP

Price per Unit: $9.61824 per GM

Product Details

What is NDC 0023-5206?

The NDC code 0023-5206 is assigned by the FDA to the product Aczone 7.5 which is a human prescription drug product labeled by Allergan, Inc.. The generic name of Aczone 7.5 is dapsone. The product's dosage form is gel and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 0023-5206-30 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump, 0023-5206-60 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump, 0023-5206-90 1 bottle, pump in 1 carton / 90 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 Aczone 7.5?

This medication is used to treat acne. It helps decrease the number and severity of acne pimples and helps pimples that do develop to heal more quickly. Dapsone is an antibiotic. It is not known how dapsone works to treat acne.

What are Aczone 7.5 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.
  • DAPSONE 75 mg/g - A sulfone active against a wide range of bacteria but mainly employed for its actions against MYCOBACTERIUM LEPRAE. Its mechanism of action is probably similar to that of the SULFONAMIDES which involves inhibition of folic acid synthesis in susceptible organisms. It is also used with PYRIMETHAMINE in the treatment of malaria. (From Martindale, The Extra Pharmacopoeia, 30th ed, p157-8)

Which are Aczone 7.5 UNII Codes?

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

Which are Aczone 7.5 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 Aczone 7.5?

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:

Which are the Pharmacologic Classes for Aczone 7.5?

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

Dapsone Topical


Dapsone topical is used to treat acne in children, teenagers, and adults. Dapsone is in a class of medications called sulfone antibiotics. It works by slowing or stopping the growth of bacteria and to decrease inflammation.
[Learn More]


* Please review the disclaimer below.

Product Label

We have moved the product label and warning information to a dedicated page, please follow the link below:

View Product Label