NDC 68462-301 Adapalene And Benzoyl Peroxide

Adapalene And Benzoyl Peroxide

NDC Product Code 68462-301

NDC 68462-301-47

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 45 g in 1 BOTTLE, PUMP

NDC 68462-301-55

Package Description: 45 g in 1 TUBE

NDC Product Information

Adapalene And Benzoyl Peroxide with NDC 68462-301 is a a human prescription drug product labeled by Glenmark Pharmaceuticals Inc., Usa. The generic name of Adapalene And Benzoyl Peroxide is adapalene and benzoyl peroxide. The product's dosage form is gel and is administered via topical form.

Labeler Name: Glenmark Pharmaceuticals Inc., Usa

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.

Product Type: Human Prescription Drug 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.

Adapalene And Benzoyl Peroxide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ADAPALENE 1 mg/g
  • BENZOYL PEROXIDE 25 mg/g

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Retinoid - [EPC] (Established Pharmacologic Class)
  • Retinoids - [CS]

Product Labeler Information

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

Labeler Name: Glenmark Pharmaceuticals Inc., Usa
Labeler Code: 68462
FDA Application Number: ANDA208108 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 11-08-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Adapalene

Adapalene is pronounced as (a dap' a leen)

Why is adapalene medication prescribed?
Adapalene is used to treat acne. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the...
[Read More]
Benzoyl Peroxide Topical

Benzoyl Peroxide Topical is pronounced as (ben' zoe il)
Why is benzoyl peroxide topical medication prescribed?
Benzoyl peroxide is used to treat mild to moderate acne....
[Read More]

* Please review the disclaimer below.

Adapalene And Benzoyl Peroxide Product Label Images