NDC 17856-0811 Nystatin

Nystatin

NDC Product Code 17856-0811

NDC Code: 17856-0811

Proprietary Name: Nystatin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Nystatin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 17856 - Atlantic Biologicals Corp.
    • 17856-0811 - Nystatin

NDC 17856-0811-1

Package Description: 120 SYRINGE in 1 BOX, UNIT-DOSE > .5 mL in 1 SYRINGE

NDC 17856-0811-2

Package Description: 120 SYRINGE in 1 BOX, UNIT-DOSE > 1 mL in 1 SYRINGE

NDC 17856-0811-3

Package Description: 120 SYRINGE in 1 BOX, UNIT-DOSE > 2 mL in 1 SYRINGE

NDC 17856-0811-4

Package Description: 48 SYRINGE in 1 BOX, UNIT-DOSE > 5 mL in 1 SYRINGE

NDC 17856-0811-5

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 5 mL in 1 CUP, UNIT-DOSE

NDC 17856-0811-6

Package Description: 120 SYRINGE in 1 BOX, UNIT-DOSE > 1 mL in 1 SYRINGE

NDC 17856-0811-7

Package Description: 120 SYRINGE in 1 BOX, UNIT-DOSE > 2 mL in 1 SYRINGE

NDC Product Information

Nystatin with NDC 17856-0811 is a a human prescription drug product labeled by Atlantic Biologicals Corp.. The generic name of Nystatin is nystatin. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Atlantic Biologicals Corp.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Nystatin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NYSTATIN 100000 [USP'U]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SUCROSE (UNII: C151H8M554)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Polyene Antifungal - [EPC] (Established Pharmacologic Class)
  • Polyenes - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Atlantic Biologicals Corp.
Labeler Code: 17856
FDA Application Number: ANDA203621 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-07-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Nystatin

Nystatin is pronounced as (nye stat' in)

Why is nystatin medication prescribed?
Nystatin is used to treat fungal infections of the inside of the mouth and lining of the stomach and intestines. Nystatin is in a class of antifungal medications called p...
[Read More]

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Nystatin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

DISTRIBUTED BY:ATLANTIC BIOLOGICALS CORP20101 N.E 16TH PLACE MIAMI, FL 33179

Description

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:C 47H 75NO 17     MW 926.13Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial peppermint flavor, cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.

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.

Indications And Usage

Nystatin oral suspension is indicated for the treatment of candidiasis in the oral cavity.

Contraindications

The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

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.

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.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Pediatric Use

See





DOSAGE AND ADMINISTRATION.

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 rarely reported.

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 of superinfections (See





CLINICAL PHARMACOLOGY, Pharmacokinetics).

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 to 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.

How Supplied

Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:NDC 17856-0811-01 NYSTATIN 100,000 UNITS/ML 0.5ML ENFIT SYRINGE 120 ct UD NDC 17856-0811-02 NYSTATIN 100,000 UNITS/ML 1ML ENFIT SYRINGE 120 ct UDNDC 17856-0811-03 NYSTATIN 100,000 UNITS/ML 2ML ENFIT SYRINGE 120 ct UDNDC 17856-0811-04 NYSTATIN 100,000 UNITS/ML 5ML ENFIT SYRINGE 48 ct UDNDC 17856-0811-05 NYSTATIN 100,000 UNITS/ML 5ML CUP 72 ct UD

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.

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