Metronidazole
Amneal Pharmaceuticals Of New York Llc
Human Prescription Drug
NDC 0115-1474Metronidazole is a human prescription drug labeled by 'Amneal Pharmaceuticals Of New York Llc'. National Drug Code (NDC) number for Metronidazole is 0115-1474. 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: | 0115-1474 |
| 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: | Amneal Pharmaceuticals Of New York Llc |
| 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: | 13 Jul, 2006 |
| 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: | ANDA077547 |
| 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: | Amneal Pharmaceuticals of New York LLC
|
| 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. |
| 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 |
|---|
| 0115-1474-46 | 1 TUBE in 1 CARTON (0115-1474-46) / 45 g in 1 TUBE | 13 Jul, 2006 | 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 carbomer homopolymer type c methylparaben propylparaben edetate disodium propylene glycol sodium hydroxide water
Drug Interactions:
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.
Indications and Usage:
Indications and usage metronidazole gel usp (topical), 0.75%, 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 usp (topical), 0.75%, twice daily, morning and evening, to entire affected areas after washing. areas to be treated should be cleansed before application of metronidazole gel usp (topical), 0.75%. patients may use cosmetics after application of metronidazole gel usp (topical), 0.75%.
Contraindications:
Contraindications metronidazole gel usp (topical), 0.75%, 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.
Drug Interactions:
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.
Use in Pregnancy:
Pregnancy teratogenic effects: pregnancy category b: there has been no experience to date with the use of metronidazole gel usp (topical), 0.75%, 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.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Description:
Description metronidazole gel usp (topical), 0.75%, contains metronidazole, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbopol 980, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. chemically, metronidazole is named 2-methyl-5-nitro-1 h -imidazole-1-ethanol and has the following structure: 29e089a5-figure-01
Clinical Pharmacology:
Clinical pharmacology bioavailability studies on the topical administration of 1 gram of metronidazole gel usp (topical), 0.75%, (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 usp (topical), 0.75%, acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory
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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 gel usp (topical), 0.75%, is supplied as the following: ndc 0115-1474-46: 45 g aluminum tube storage and handling storage conditions: store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. to report suspected adverse reactions contact amneal pharmaceuticals at 1-877-835-5472 or fda at 1-800-fda-1088 or www.fda.gov/medwatch . manufactured by: tolmar, inc. fort collins, co 80526 distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 04006127 rev. 0 04/19
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.principal display panel 45g carton packaging 45g carton packaging