NDC 0472-1736 Miconazole 7

Miconazole Nitrate

NDC Product Code 0472-1736

NDC CODE: 0472-1736

Proprietary Name: Miconazole 7 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Miconazole Nitrate 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

NDC Code Structure

  • 0472 - Actavis Pharma, Inc.

NDC 0472-1736-07

Package Description: 7 SUPPOSITORY in 1 BOX

Price per Unit: $0.90633 per EA

NDC Product Information

Miconazole 7 with NDC 0472-1736 is a a human over the counter drug product labeled by Actavis Pharma, Inc.. The generic name of Miconazole 7 is miconazole nitrate. The product's dosage form is suppository and is administered via vaginal form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 992780.

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

Product Type: Human Otc Drug 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.

Miconazole 7 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
  • PALM KERNEL OIL (UNII: B0S90M0233)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Vaginal - Administration into the vagina.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Actavis Pharma, Inc.
Labeler Code: 0472
FDA Application Number: ANDA073507 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 03-01-1997 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Information for Patients

Miconazole

Miconazole is pronounced as (mi kon' a zole)

Why is miconazole medication prescribed?
Miconazole, an antifungal agent, is used for skin infections such as athlete's foot and jock itch and for vaginal yeast infections.This medication is sometimes prescribed...
[Read More]

* Please review the disclaimer below.

Miconazole 7 Product Label Images

Miconazole 7 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Vaginal Suppository)

Miconazole nitrate, USP 100 mg

Purpose

Vaginal antifungal

Use

  • Treats vaginal yeast infections

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 timevaginal 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 a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

When Using This Product

  • Do not use tampons, douches, spermicides or other vaginal productsdo 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 dayssymptoms last more than 7 daysyou 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 right away.

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

Other Information

  • Do not purchase if carton is openeach suppository is individually wrapped. Do not use if wrapper is missing or damaged.store at room temperature 15°-30°C (59°-86°F), avoid heat over 30°C or 86°F.

Inactive Ingredient

Hydrogenated vegetable oil

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

* Please review the disclaimer below.