Metronidazole
Fougera Pharmaceuticals Inc.
Human Prescription Drug
NDC 0168-0323Metronidazole is a human prescription drug labeled by 'Fougera Pharmaceuticals Inc.'. National Drug Code (NDC) number for Metronidazole is 0168-0323. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Metronidazole drug includes Metronidazole - 7.5 mg/g . The currest status of Metronidazole drug is Active.
Drug Information:
| Drug NDC: | 0168-0323 |
| 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: | Metronidazole |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Metronidazole |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fougera Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | METRONIDAZOLE - 7.5 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 28 May, 2004 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jan, 2026 |
| 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: | ANDA076408 |
| 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, 2023 |
| 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: | Fougera Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 311678
|
| 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. |
| UPC: | 0301680323466
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175435
M0014907
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 140QMO216E
|
| 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 EPC: | Nitroimidazole Antimicrobial [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Nitroimidazoles [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Nitroimidazole Antimicrobial [EPC]
Nitroimidazoles [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 |
|---|
| 0168-0323-46 | 45 g in 1 TUBE (0168-0323-46) | 28 May, 2004 | 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. |
Product Elements:
Metronidazole metronidazole metronidazole metronidazole sorbitol glycerin isopropyl palmitate benzyl alcohol lactic acid, unspecified form sodium hydroxide water
Drug Interactions:
Drug interactions: oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. the effect of topical metronidazole on prothrombin time is not known.
Indications and Usage:
Indications and usage metronidazole topical cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
General Precautions:
General: topical metronidazole 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.
Dosage and Administration:
Dosage and administration apply and rub in a thin layer of metronidazole topical cream twice daily, morning and evening, to entire affected areas after washing. areas to be treated should be washed with a mild cleanser before application. patients may use cosmetics after application of metronidazole topical cream.
Contraindications:
Contraindications metronidazole topical cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.
Adverse Reactions:
Adverse reactions in controlled clinical trials, the total incidence of adverse reactions associated with the use of metronidazole topical cream was approximately 10%. skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. all individual events occurred in less than 3% of patients. the following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
Drug Interactions:
Drug interactions: oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. the effect of topical metronidazole on prothrombin time is not known.
Use in Pregnancy:
Pregnancy: teratogenic effects: pregnancy category b there are no adequate and well-controlled studies with the use of metronidazole topical cream in pregnant women. 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.
Pediatric Use:
Pediatric use: safety and effectiveness in pediatric patients have not been established.
Description:
Description metronidazole topical cream contains metronidazole, usp, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid, and/or sodium hydroxide to adjust ph, and purified water. metronidazole is a member of the imidazole class of anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. chemically, metronidazole is 2-methyl-5-nitroimidazole-1-ethanol. the molecular formula is c 6 h 9 n 3 o 3 and molecular weight is 171.16. metronidazole is represented by the following structural formula: structure
Clinical Pharmacology:
Clinical pharmacology the mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
How Supplied:
How supplied metronidazole topical cream 0.75% is supplied in a 45 gram tube, ndc 0168-0323-46 storage conditions: store at 20°c to 25°c (68°f to 77°f), excursions permitted 15°c to 30°c (59°f to 86°f). [see usp controlled room temperature]. e. fougera & co. a division of fougera pharmaceuticals inc. melville, new york 11747 46273863a r07/2020 #29
Information for Patients:
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.
Package Label Principal Display Panel:
Package label â principal display panel â 45 gram tube ndc 0168-0323-46 fougera® metronidazole topical cream 0.75% rx only for topical use only not for ophthalmic use store at 20°c to 25°c (68°f to 77°f), excursions permitted 15°c to 30°c (59°f to 86°f). [see usp controlled room temperature]. keep out of the reach of children. net wt 45 grams 45gramtubelabel
Package label â principal display panel â 45 gram carton ndc 0168-0323-46 rx only fougera® metronidazole topical cream 0.75% for topical use only not for ophthalmic use net wt 45 grams 45gcarton