NDC 52925-512 Vcf Contraceptive Pre-filled Applicators

Nonoxynol-9 Gel, Metered Vaginal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
52925-512
Proprietary Name:
Vcf Contraceptive Pre-filled Applicators
Non-Proprietary Name: [1]
Nonoxynol-9
Substance Name: [2]
Nonoxynol-9
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel, Metered - A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.
Administration Route(s): [4]
  • Vaginal - Administration into the vagina.
  • Labeler Code:
    52925
    FDA Application Number: [6]
    part333A
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    06-01-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)

    Code Structure Chart

    Product Details

    What is NDC 52925-512?

    The NDC code 52925-512 is assigned by the FDA to the product Vcf Contraceptive Pre-filled Applicators which is a human over the counter drug product labeled by Apothecus Pharmaceutical Corp. The generic name of Vcf Contraceptive Pre-filled Applicators is nonoxynol-9. The product's dosage form is gel, metered and is administered via vaginal form. The product is distributed in 2 packages with assigned NDC codes 52925-512-10 10 applicator in 1 box / 2.55 g in 1 applicator, 52925-512-25 250 applicator in 1 carton / 2.55 g in 1 applicator. 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 Vcf Contraceptive Pre-filled Applicators?

    For maximum protection against unwanted pregnancy, follow the enclosed directions exactly.Insert one applicatorful into the vagina prior to intercourse (see complete, illustrated directions on package insert).Each applicatorful is effective immediately and up to one hour after application.An additional applicatorful is required prior to each act of intercourse, regardless of time since last application.

    What are Vcf Contraceptive Pre-filled Applicators 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.
    • NONOXYNOL-9 4 g/100g - Nonionic surfactant mixtures varying in the number of repeating ethoxy (oxy-1,2-ethanediyl) groups. They are used as detergents, emulsifiers, wetting agents, defoaming agents, etc. Nonoxynol-9, the compound with 9 repeating ethoxy groups, is a spermatocide, formulated primarily as a component of vaginal foams and creams.

    Which are Vcf Contraceptive Pre-filled Applicators UNII Codes?

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

    Which are Vcf Contraceptive Pre-filled Applicators 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 Vcf Contraceptive Pre-filled Applicators?

    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:

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    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".