NDC 51672-4117 Nystatin

Nystatin

  1. Labeler Index
  2. Taro Pharmaceuticals U.s.a., Inc.
  3. NDC: 51672-4117 Nystatin

NDC Product Code 51672-4117

NDC CODE: 51672-4117

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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • Nystatin is used to treat fungal skin infections. Nystatin is an antifungal that works by stopping the growth of fungus.

NDC Code Structure

NDC 51672-4117-0

Package Description: 3785 mL in 1 BOTTLE

NDC 51672-4117-4

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 60 mL in 1 BOTTLE, DROPPER

NDC 51672-4117-9

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Nystatin with NDC 51672-4117 is a a human prescription drug product labeled by Taro Pharmaceuticals U.s.a., Inc.. The generic name of Nystatin is nystatin. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Taro Pharmaceuticals U.s.a., Inc.

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)
  • BENZALDEHYDE (UNII: TA269SD04T)
  • EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Taro Pharmaceuticals U.s.a., Inc.
Labeler Code: 51672
FDA Application Number: ANDA062876 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: 02-29-1988 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: 12-31-2021 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 skin, mouth, vagina, and intestinal tract. Fungal medicines will not work for colds, flu, or other viral infections.Thi...
[Read More]

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Nystatin Product Label Images

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

Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, N.Y. 10532Revised: March, 201070564-0310-1

Description

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:Nystatin Oral Suspension, for oral administration, is cherry/mint flavored, containing 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤1% v/v), benzaldehyde, edetate calcium disodium, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, sucrose 49.8% (w/v), xanthan gum.

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).

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.

How Supplied

Nystatin Oral Suspension, USP, 100,000 USP Nystatin U/mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in:2 fl oz (60 mL) bottles with 0.5 mL, 1 mL, 1.5 mL, 2 mL calibrated dropperNDC 51672-4117-41 Pint (473 mL) bottlesNDC 51672-4117-91 Gallon (3785 mL) bottles (For repackaging only)NDC 51672-4117-0SHAKE WELL BEFORE USING

Storage

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing.PHARMACIST: Dispense in a tight, light-resistant container as defined in USP.

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