Nystatin
Macleods Pharmaceuticals Limited
Human Prescription Drug
NDC 33342-481Nystatin is a human prescription drug labeled by 'Macleods Pharmaceuticals Limited'. National Drug Code (NDC) number for Nystatin is 33342-481. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Nystatin drug includes Nystatin - 100000 1/g . The currest status of Nystatin drug is Active.
Drug Information:
| Drug NDC: | 33342-481 |
| 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: | Nystatin |
| 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: | Nystatin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Macleods Pharmaceuticals Limited |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | NYSTATIN - 100000 1/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: | 29 Jan, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | ANDA213826 |
| 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: | Macleods Pharmaceuticals Limited
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 884308
|
| 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: | N0000175498
M0017172
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | BDF1O1C72E
|
| 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: | Polyene Antifungal [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: | Polyenes [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: | Polyene Antifungal [EPC]
Polyenes [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 |
|---|
| 33342-481-15 | 1 TUBE in 1 CARTON (33342-481-15) / 15 g in 1 TUBE | 29 Jan, 2021 | N/A | No |
| 33342-481-30 | 1 TUBE in 1 CARTON (33342-481-30) / 30 g in 1 TUBE | 29 Jan, 2021 | 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:
Nystatin nystatin nystatin nystatin light mineral oil petrolatum
Indications and Usage:
Indications and usage nystatin ointment, is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by candida albicans and other susceptible candida species. nystatin ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage and Administration:
Dosage & administration nystatin ointment adults and pediatric patients (neonates and older): apply liberally to affected areas twice daily or as indicated until healing is complete.
Contraindications:
Contraindications nystatin ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
Adverse Reactions:
Adverse reactions the frequency of adverse events reported in patients using nystatin ointment preparations is less than 0.1%. the more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (see precautions: general.) to report suspected adverse reactions, contact macleods pharma usa, inc., at 1-888-943-3210 or 1-855-926-338 or fda at 1-800-fda-1088 ( www.fda.gov/medwatch ).
Use in Pregnancy:
Pregnancy: teratogenic effects animal reproduction studies have not been conducted with any nystatin topical preparation. it also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
Pediatric Use:
Pediatric use safety and effectiveness have been established in the pediatric population from birth to 16 years. see dosage and administration
Description:
Description nystatin is a polyene antifungal antibiotic drug obtained from streptomyces nursei nystatin ointment usp, for topical use only, contains 100,000 usp nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. the structural formula is as follows: molecular weight 926.13 molecular formula c 47 h 75 no 17 structure.jpg
Clinical Pharmacology:
Clinical pharmacology pharmacokinetics nystatin is not absorbed from intact skin or mucous membrane. microbiology nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including candida albicans, c. parapsilosis, c. tropicalis, c. guilliermondi, c. pseudotropicalis, c. krusei, torulopsis glabrata, tricophyton rubrum, t. mentagrophytes. nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. on repeated subculturing with increasing concentrations of nystatin, candida albicans does not develop resistance to nystatin.generally, resistance to nystatin does not develop during therapy. however, other species of 47 75 17 candida (c. tropicalis, c. guilliermondi, c. krusei, and c. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to ampho
Read more...tericin as well. this resistance is lost when the antibiotic is removed. nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenisis, mutagenisis, impairment of fertility no long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. no studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.
How Supplied:
How supplied nystatin ointment (100,000 usp nystatin units per gram) is a yellowish ointment available as follows: ndc 33342-481-15 15 gram tube ndc 33342-481-30 30 gram tube store at 20° to 25°c (68° to 77°f); excursions permitted between 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. manufactured for: macleods pharma usa, inc. princeton, nj 08540 manufacturer: macleods pharmaceuticals limited at oxalis labs baddi, himachal pradesh, india rev. 01/2021
Information for Patients:
Information for the patients patients using these medications should receive the following information and instructions : 1. the patient should be instructed to use these medications as directed (including the replacement of missed doses). these medications are not for any disorder other than that for which they are prescribed. 2. even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. 3. if symptoms of irritation develop, the patient should be advised to notify the physician promptly.
Package Label Principal Display Panel:
Package label.principal display panel nystatin ointment (100,000 usp nystatin units per gram) pack count: 15 g tube ndc 33342-481-15 nystatin ointment (100,000 usp nystatin units per gram) pack count: 15 g carton ndc 33342-481-15 nystatin ointment (100,000 usp nystatin units per gram) pack count: 30 g tube ndc 33342-481-30 nystatin ointment (100,000 usp nystatin units per gram) pack count: 30 g carton ndc 33342-481-30 nystatin-tube-15-gm nystatin-carton-15-gm nystatin-tube-30-gm nystatin-carton-30-gm