Vcf Contraceptive Pre-filled Applicators
Nonoxynol-9
Apothecus Pharmaceutical Corp
Human Otc Drug
NDC 52925-512Vcf Contraceptive Pre-filled Applicators also known as Nonoxynol-9 is a human otc drug labeled by 'Apothecus Pharmaceutical Corp'. National Drug Code (NDC) number for Vcf Contraceptive Pre-filled Applicators is 52925-512. This drug is available in dosage form of Gel, Metered. The names of the active, medicinal ingredients in Vcf Contraceptive Pre-filled Applicators drug includes Nonoxynol-9 - 4 g/100g . The currest status of Vcf Contraceptive Pre-filled Applicators drug is Active.
Drug Information:
| Drug NDC: | 52925-512 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Vcf Contraceptive Pre-filled Applicators |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Nonoxynol-9 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Apothecus Pharmaceutical Corp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel, Metered |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | NONOXYNOL-9 - 4 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | VAGINAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jun, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333A |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | APOTHECUS PHARMACEUTICAL CORP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198765
1597814
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 48Q180SH9T
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52925-512-10 | 10 APPLICATOR in 1 BOX (52925-512-10) / 2.55 g in 1 APPLICATOR | 01 Jun, 2014 | N/A | No |
| 52925-512-25 | 250 APPLICATOR in 1 CARTON (52925-512-25) / 2.55 g in 1 APPLICATOR | 01 Jun, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose vaginal contraceptive
Product Elements:
Vcf contraceptive pre-filled applicators nonoxynol-9 nonoxynol-9 nonoxynol-9 water propylene glycol sodium benzoate sorbitol povidone k30 lactic acid, unspecified form methylparaben potassium sorbate edetate trisodium
Indications and Usage:
Use for the prevention of pregnancy with condom or alone
Warnings:
Warnings for vaginal use only not for rectal (anal) use. sexually transmitted disease (stds) alert this product does not protect against hiv (aids) or other stds and may increase the risk of getting hiv from an infected partner. do not use if you or your sex partner has hiv/aids. if you do not know if you or your sex partner is infected, choose another form of birth control stop use and ask a doctor if you or your partner get burning, itching, a rash, or other irritation of the vagina or penis. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for vaginal use only not for rectal (anal) use. sexually transmitted disease (stds) alert this product does not protect against hiv (aids) or other stds and may increase the risk of getting hiv from an infected partner. do not use if you or your sex partner has hiv/aids. if you do not know if you or your sex partner is infected, choose another form of birth control stop use and ask a doctor if you or your partner get burning, itching, a rash, or other irritation of the vagina or penis. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions 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.
Stop Use:
Stop use and ask a doctor if you or your partner get burning, itching, a rash, or other irritation of the vagina or penis.
Package Label Principal Display Panel:
Principal display panel - 2.55 g applicator box new! compare to conceptrol ® ! vcf ® vaginal contraceptive gel for prevention of pregnancy pre-filled applicators safe and effective hormone free easy to use contains the spermicide doctors recommend most 10 pre-filled applicators net wt. 0.09 oz. (2.55g) each principal display panel - 2.55 g applicator box
Further Questions:
Questions? if you have any questions, call our toll-free line at 1-800-879-2393 between 9:00am and 5:00pm est, monday through friday.