Nystatin
Leading Pharma, Llc
Human Prescription Drug
NDC 69315-504Nystatin is a human prescription drug labeled by 'Leading Pharma, Llc'. National Drug Code (NDC) number for Nystatin is 69315-504. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Nystatin drug includes Nystatin - 100000 [USP'U]/mL . The currest status of Nystatin drug is Active.
Drug Information:
| Drug NDC: | 69315-504 |
| 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: | Leading Pharma, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension |
| 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 [USP'U]/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 05 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 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: | ANDA214346 |
| 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: | Leading Pharma, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312055
|
| 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: | 0369315504475
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 69315-504-47 | 473 mL in 1 BOTTLE (69315-504-47) | 05 Dec, 2022 | N/A | No |
| 69315-504-60 | 1 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLE | 05 Dec, 2022 | 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 alcohol sucrose peppermint oil cinnamaldehyde sodium phosphate, dibasic, anhydrous carboxymethylcellulose sodium glycerin saccharin sodium methylparaben propylparaben water sodium hydroxide hydrochloric acid light creamy yellow cherry-mint flavored
Indications and Usage:
Indications and usage nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by candida albicans.
Dosage and Administration:
Dosage and administration infants: 2 ml (200,000 units) four times daily (1 ml in each side of mouth). pediatric patients and adults: 4 to 6 ml (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). note: limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 ml (100,000 units) four times daily is effective. local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. it is recommended that the drug be retained in the mouth as long as possible before swallowing.
Contraindications:
Contraindications nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.
Adverse Reactions:
Adverse reactions to report suspected adverse reactions, contact fda at 1-800-fda-1088 or leading pharma, llc at 1-844-740-7500 or www.fda.gov/medwatch. gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.
Overdosage:
Overdosage oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.
Description:
Description nystatin is obtained from streptomyces noursei. it is known to be a mixture, but the composition has not been completely elucidated. nystatin a is closely related to amphotericin b. each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. structural formula: nystatin oral suspension, for oral administration, contains 100,000 usp nystatin units per ml. inactive ingredients: alcohol (⤠1% v/v), sucrose 50% w/v, peppermint oil, nf, cinnamaldehyde, disodium hydrogen phosphate, usp, carboxymethylcellulose sodium, usp, glycerin, usp, saccharin sodium, usp, cherry flavor, methylparaben, nf, propylparaben, nf and purified water, usp. may also contain sodium hydroxide, nf and/ or hydrochloric acid, nf for ph adjustment. chemstructure
Clinical Pharmacology:
Clinical pharmacology nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.
How Supplied:
How supplied nystatin oral suspension, usp, 100,000 usp nystatin units per ml, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension, in the following sizes: 60 ml bottles with a child-resistant cap and calibrated dropper. 1 pint (473 ml) bottles with a child-resistant cap. storage this package is child-resistant. keep out of reach of children. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. avoid freezing ndc for 60 ml: 69315-504-60 ndc for 473 ml: 69315-504-47 rx only
Package Label Principal Display Panel:
Containerlabel-60ml cartonlabel-60ml containerlabel-473ml