NDC 99207-270 Zyclara

Imiquimod Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
99207-270
Proprietary Name:
Zyclara
Non-Proprietary Name: [1]
Imiquimod
Substance Name: [2]
Imiquimod
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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]
    Bausch Health Us, Llc
    Labeler Code:
    99207
    FDA Application Number: [6]
    NDA022483
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    11-28-2011
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 99207-270-01

    Package Description: 4 PACKET in 1 CARTON / .25 g in 1 PACKET

    NDC Code 99207-270-28

    Package Description: 28 PACKET in 1 CARTON / .25 g in 1 PACKET

    Price per Unit: $36.08359 per EA

    Product Details

    What is NDC 99207-270?

    The NDC code 99207-270 is assigned by the FDA to the product Zyclara which is a human prescription drug product labeled by Bausch Health Us, Llc. The generic name of Zyclara is imiquimod. The product's dosage form is cream and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 99207-270-01 4 packet in 1 carton / .25 g in 1 packet, 99207-270-28 28 packet in 1 carton / .25 g in 1 packet. 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 Zyclara?

    Imiquimod is used to treat actinic keratoses (AK) which are precancerous growths on the skin. AK are caused by too much sun exposure. Treating this condition can decrease the risk of complications from them. It is also used to treat warts on the outside of the genitals/anus. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths. This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.

    What are Zyclara 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.
    • IMIQUIMOD 37.5 mg/g - A topically-applied aminoquinoline immune modulator that induces interferon production. It is used in the treatment of external genital and perianal warts, superficial CARCINOMA, BASAL CELL; and ACTINIC KERATOSIS.

    Which are Zyclara UNII Codes?

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

    Which are Zyclara 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 Zyclara?

    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 Zyclara?

    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

    Imiquimod Topical


    Imiquimod cream is used to treat certain types of actinic keratoses (flat, scaly growths on the skin caused by too much sun exposure) on the face or scalp. Imiquimod cream is also used to treat superficial basal cell carcinoma (a type of skin cancer) on the trunk, neck, arms, hands, legs, or feet and warts on the skin of the genital and anal areas. Imiquimod is in a class of medications called immune response modifiers. It treats genital and anal warts by increasing the activity of the body's immune system. It is not known exactly how imiquimod cream works to treat actinic keratoses or superficial basal cell carcinoma. Imiquimod cream does not cure warts, and new warts may appear during treatment. It is not known whether imiquimod cream prevents the spread of warts to other people.
    [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".