Metronidazole
Cosette Pharmaceuticals, Inc.
Human Prescription Drug
NDC 0713-0637Metronidazole is a human prescription drug labeled by 'Cosette Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Metronidazole is 0713-0637. This drug is available in dosage form of Gel. 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: | 0713-0637 |
| 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: | Cosette Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | 01 Apr, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ANDA078178 |
| 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: | Cosette Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 311679
|
| 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: | 0307130637374
|
| 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 |
|---|
| 0713-0637-37 | 1 TUBE in 1 CARTON (0713-0637-37) / 45 g in 1 TUBE | 01 Apr, 2011 | 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 methylparaben propylparaben carbomer homopolymer type c edetate disodium propylene glycol water sodium hydroxide metronidazole metronidazole
Indications and Usage:
Indications and usage: metronidazole gel usp is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage and Administration:
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.
Contraindications:
Contraindications: metronidazole gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.
Adverse Reactions:
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. to report suspected adverse reactions, contact cosette pharmaceuticals, inc. at 1-800-922-1038 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Description:
Description: metronidazole gel usp, 0.75% contains metronidazole, usp, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer nf, 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-1 h -imidazole-1-ethanol and has the following structure: structural formula
Clinical Pharmacology:
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.
How Supplied:
How supplied: metronidazole gel usp, 0.75% is supplied in a 45 g tube ndc 0713-0637-37 storage conditions: store at 20º-25ºc (68º-77ºf) [see usp controlled room temperature]. distributed by: cosette pharmaceuticals, inc. south plainfield, nj 07080 8-0637bfcplnc3 rev. 07/2022 vc7647
Package Label Principal Display Panel:
Principal display panel ndc 0713-0637-37 metronidazole gel usp 0.75% 45 g rx only for topical use only. not for ophthalmic use. cosette pharmaceuticals, inc. ndc 0713-0637-37 metronidazole gel usp 0.75% 45 g rx only for topical use only. not for ophthalmic use. cosette pharmaceuticals, inc. carton tube