NDC 68682-513 Tretinoin

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

Product Information

NDC Product Code:
68682-513
Proprietary Name:
Tretinoin
Non-Proprietary Name: [1]
Tretinoin
Substance Name: [2]
Tretinoin
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]
    Oceanside Pharmaceuticals
    Labeler Code:
    68682
    FDA Application Number: [6]
    NDA020475
    Marketing Category: [8]
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date: [9]
    03-14-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 68682-513-82

    Package Description: 1 TUBE in 1 CARTON / 20 g in 1 TUBE

    Price per Unit: $11.22256 per GM

    NDC Code 68682-513-84

    Package Description: 1 TUBE in 1 CARTON / 45 g in 1 TUBE

    Price per Unit: $8.85347 per GM

    NDC Code 68682-513-85

    Package Description: 1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP

    Price per Unit: $10.17337 per GM

    Product Details

    What is NDC 68682-513?

    The NDC code 68682-513 is assigned by the FDA to the product Tretinoin which is a human prescription drug product labeled by Oceanside Pharmaceuticals. The product's dosage form is gel and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 68682-513-82 1 tube in 1 carton / 20 g in 1 tube, 68682-513-84 1 tube in 1 carton / 45 g in 1 tube, 68682-513-85 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 Tretinoin?

    This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.

    What are Tretinoin 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.
    • TRETINOIN 1 mg/g - An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).

    Which are Tretinoin UNII Codes?

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

    Which are Tretinoin 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 Tretinoin?

    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 Tretinoin?

    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

    Tretinoin Topical


    Tretinoin (Altreno, Atralin, Avita, Retin-A) is used to treat acne. Tretinoin is also used to reduce fine wrinkles (Refissa and Renova) and to improve spotty discoloration (Renova) and rough feeling skin (Renova) when used along with other skin care and sunlight avoidance programs. Tretinoin is in a class of medications called retinoids. It works by promoting peeling of affected skin areas and unclogging pores.
    [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".