NDC 42546-700 Metronidazole

Product Information

Metronidazole is product labeled by Prugen, Inc.. The product's dosage form is and is administered via form.

Product Code42546-700
Proprietary Name 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.
Metronidazole
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Prugen, Inc.
Labeler Code42546
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-18-2006
Listing Expiration Date 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.
12-31-2019
Exclude Flag 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".
I
NDC Code Structure

What are the uses for Metronidazole?


Product Characteristics

Color(s)YELLOW (C48330 - COLORLESS TO PALE YELLOW)

Product Packages

NDC 42546-700-45

Package Description: 1 TUBE in 1 CARTON > 45 g in 1 TUBE

Price per Unit: $1.63734 per GM

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Metronidazole 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.
  • METRONIDAZOLE (UNII: 140QMO216E)
  • METRONIDAZOLE (UNII: 140QMO216E) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? 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:

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.
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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Patient Education

Metronidazole Topical

Metronidazole Topical is pronounced as (me troe ni' da zole)

Why is metronidazole topical medication prescribed?
Metronidazole is used to treat acne rosacea (adult acne), a chronic condition in which the facial skin is inflamed and sores develop. Metronidazole decreases the redness ...
[Read More]

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Metronidazole Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Rx Only

FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE

Mfd. for:
PruGen Pharmaceuticals
Scottsdale, AZ 85255
www.prugen.com
Rev 2.0

Made in Israel

Revised: April, 2015

20768-0415-0 705


Description



Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:


Clinical Pharmacology



Bioavailability studies on the topical administration of 1 gram of metronidazole gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole. The mechanisms by which metronidazole gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.


Indications And Usage



Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.


Contraindications



Metronidazole gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.


General



Metronidazole gel has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.

Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.


Information For Patients



This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


Drug Interactions



Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.


Carcinogenesis, Mutagenesis, Impairment Of Fertility



Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.


Pregnancy Category B



There has been no experience to date with the use of metronidazole gel in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.


Nursing Mothers



After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though metronidazole gel blood levels are significantly lower than those achieved after oral metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


Pediatric Use



Safety and effectiveness in pediatric patients have not been established.


Adverse Reactions



The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.


Dosage And Administration



Apply and rub in a thin film of metronidazole gel twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole gel. Patients may use cosmetics after application of metronidazole gel.


How Supplied



Metronidazole Gel USP, 0.75% is supplied in aluminum tubes containing:
45 g NDC 42546-700-45


Storage And Handling



Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].


Principal Display Panel - 45 G Tube Carton



NDC 42546-700-45

45 g

Rx only

Metronidazole
GEL USP, 0.75%

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Keep this and all medications out of the reach of children.

PRUGEN
PHARMACEUTICALS


* Please review the disclaimer below.