Nystatin Oral Suspension
Nucare Pharmaceuticals,inc.
Human Prescription Drug
NDC 68071-2644Nystatin Oral Suspension is a human prescription drug labeled by 'Nucare Pharmaceuticals,inc.'. National Drug Code (NDC) number for Nystatin Oral Suspension is 68071-2644. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Nystatin Oral Suspension drug includes Nystatin - 100000 [USP'U]/mL . The currest status of Nystatin Oral Suspension drug is Active.
Drug Information:
| Drug NDC: | 68071-2644 |
| 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 Oral Suspension |
| 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 Oral Suspension |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nucare Pharmaceuticals,inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | 28 Jun, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 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: | ANDA065148 |
| 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: | NuCare Pharmaceuticals,Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UPC: | 0368071264463
|
| 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 |
|---|
| 68071-2644-6 | 1 BOTTLE, DROPPER in 1 CARTON (68071-2644-6) / 60 mL in 1 BOTTLE, DROPPER | 21 Feb, 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 oral suspension nystatin oral suspension alcohol carboxymethylcellulose sodium glycerin methylparaben propylparaben water saccharin sodium sodium citrate sucrose anhydrous citric acid nystatin nystatin light creamy yellow cherry-mint flavored
Indications and Usage:
Indications and usage nystatin oral suspension is indicated for the treatment of candidiasis in the oral cavity.
General Precautions:
General this medication is not to be used for the treatment of systemic mycoses. discontinue treatment if sensitization or irritation is reported during use.
Dosage and Administration:
Dosage and administration infants: 2 ml (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). note: limited clinical studies in premature and low birth weight infants indicate that 1 ml four times daily is effective. children and adults: 4-6 ml (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). the preparation should be retained in the mouth as long as possible before swallowing. continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of candida albicans .
Contraindications:
Contraindications the preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
Adverse Reactions:
Adverse reactions nystatin is well tolerated even with prolonged therapy. oral irritation and sensitization have been reported (see precautions : general ). gastrointestinal: diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. dermatologic: rash, including urticaria has been reported rarely. stevens-johnson syndrome has been reported very rarely. other: tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been reported.
Use in Pregnancy:
Pregnancy teratogenic effects category c animal reproduction studies have not been conducted with nystatin oral suspension. it is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. nystatin oral suspension should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use see dosage and administration .
Overdosage:
Overdosage oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. there have been no reports of serious toxic effects or superinfections (see clinical pharmacology , pharmacokinetics ).
Description:
Description nystatin is an antimycotic polyene antibiotic obtained from streptomyces noursei . structural formula: nystatin oral suspension is a cherry-mint flavored suspension for oral administration. it contains 100,000 usp nystatin units per ml. inactive ingredients: alcohol (⤠1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). may also contain citric acid for ph adjustment. structure
Clinical Pharmacology:
Clinical pharmacology pharmacokinetics gastrointestinal absorption of nystatin is insignificant. most orally administered nystatin is passed unchanged in the stool. in patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur. microbiology nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other candida species become quite resistant. generally, resistance does not develop in vivo . nystatin acts by binding to sterols in the cell membrane of susceptible candida species with a resultant change in membrane permeability allowing leakage of intracellular components. nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
Pharmacodynamics:
Pharmacokinetics gastrointestinal absorption of nystatin is insignificant. most orally administered nystatin is passed unchanged in the stool. in patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
Pharmacokinetics:
Microbiology nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other candida species become quite resistant. generally, resistance does not develop in vivo . nystatin acts by binding to sterols in the cell membrane of susceptible candida species with a resultant change in membrane permeability allowing leakage of intracellular components. nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no long-term animal studies have been performed to evaluate carcinogenic potential. there also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
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 60 ml bottles with calibrated dropper and 473 ml bottles. it is supplied as follows: ndc 68071-2644-6 60 ml storage store at 20°-25°c (68°-77°f) with excursions permitted between 15°-30°c (59°-86°f) [see usp controlled room temperature]; avoid freezing. distributed by: lannett company, inc. philadelphia, pa 19136 l7046 rev. 09/19
Package Label Principal Display Panel:
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