Miconazole 7
Miconazole Nitrate
H2-pharma, Llc
Human Otc Drug
NDC 61269-736Miconazole 7 also known as Miconazole Nitrate is a human otc drug labeled by 'H2-pharma, Llc'. National Drug Code (NDC) number for Miconazole 7 is 61269-736. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in Miconazole 7 drug includes Miconazole Nitrate - 100 mg/1 . The currest status of Miconazole 7 drug is Active.
Drug Information:
| Drug NDC: | 61269-736 |
| 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: | Miconazole 7 |
| 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: | Miconazole Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | H2-pharma, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suppository |
| 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: | MICONAZOLE NITRATE - 100 mg/1
|
| 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: | ANDA |
| 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: | 24 May, 2021 |
| 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: | ANDA073507 |
| 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: | H2-Pharma, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 992780
|
| 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: | VW4H1CYW1K
|
| 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. |
| Pharmacologic Class: | Azole Antifungal [EPC]
Azoles [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 61269-736-07 | 7 SUPPOSITORY in 1 BOX (61269-736-07) | 24 May, 2021 | 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 antifungal
Product Elements:
Miconazole 7 miconazole nitrate miconazole nitrate miconazole hydrogenated palm kernel oil palm kernel oil
Indications and Usage:
Use treats vaginal yeast infections
Warnings:
Warnings for vaginal use only do not use if you have never had a vaginal yeast infection diagnosed by a doctor. ask a doctor before use if you have vaginal itching and discomfort for the first time vaginal yeast infections often (such as once a month or 3 in 6 months). you may have a more serious condition. you could be pregnant or have a medical condition, such as diabetes or a weakened immune system. lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge been exposed to the human immunodeficiency virus (hiv) that causes aids ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. when using this product do not use tampons, douches, spermicides or other vaginal products do not use condoms or diaphragms. they may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (stds). do not have vaginal intercourse (sex)
Read more...mild increase in vaginal burning, itching or irritation may occur stop use and ask a doctor if side effects occur symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
Do Not Use:
Warnings for vaginal use only do not use if you have never had a vaginal yeast infection diagnosed by a doctor. ask a doctor before use if you have vaginal itching and discomfort for the first time vaginal yeast infections often (such as once a month or 3 in 6 months). you may have a more serious condition. you could be pregnant or have a medical condition, such as diabetes or a weakened immune system. lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge been exposed to the human immunodeficiency virus (hiv) that causes aids ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. when using this product do not use tampons, douches, spermicides or other vaginal products do not use condoms or diaphragms. they may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (stds). do not have vaginal intercourse (sex) mild increase in vaginal burning, itching or irritation may occur stop use and ask a doctor if side effects occur symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product do not use tampons, douches, spermicides or other vaginal products do not use condoms or diaphragms. they may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (stds). do not have vaginal intercourse (sex) mild increase in vaginal burning, itching or irritation may occur
Dosage and Administration:
Directions before using this product read the enclosed consumer information leaflet for complete instructions and information adults and children 12 years of age and over: insert 1 suppository into the vagina at bedtime for 7 nights in a row. wash applicator after use. children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if side effects occur symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
Package Label Principal Display Panel:
Principal display panel - 100 mg suppository box ndc 61269-736-07 *compare to the active ingredient in monistat® 7 miconazole 7 miconazole nitrate vaginal suppositories, usp 100 mg vaginal antifungal cures most vaginal yeast infections 7 vaginal suppositories with 1 reusable plastic applicator h 2 pharma principal display panel - 100 mg suppository box
Further Questions:
Questions? call 1-877-753-3935 monday-friday 9am-5pm est