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NDC 53489-0400-02 Nystatin 500000 [USP'U]/1 Details
Nystatin 500000 [USP'U]/1
Nystatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is NYSTATIN.
MedlinePlus Drug Summary
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 polyenes. It works by stopping the growth of fungi that cause infection.
Related Packages: 53489-0400-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nystatin
Product Information
| NDC | 53489-0400 |
|---|---|
| Product ID | 53489-400_2628bf08-c7f5-4aef-8e14-bf987eca87ea |
| Associated GPIs | 11000060000305 |
| GCN Sequence Number | 009538 |
| GCN Sequence Number Description | nystatin TABLET 500K UNIT ORAL |
| HIC3 | W3A |
| HIC3 Description | ANTIFUNGAL ANTIBIOTICS |
| GCN | 42452 |
| HICL Sequence Number | 004129 |
| HICL Sequence Number Description | NYSTATIN |
| Brand/Generic | Generic |
| Proprietary Name | Nystatin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | nystatin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500000 |
| Active Ingredient Units | [USP'U]/1 |
| Substance Name | NYSTATIN |
| Labeler Name | Sun Pharmaceutical Industries, Inc. |
| Pharmaceutical Class | Polyene Antifungal [EPC], Polyenes [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA062838 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 53489-0400-02 (53489040002)
| NDC Package Code | 53489-400-02 |
|---|---|
| Billing NDC | 53489040002 |
| Package | 50 TABLET, FILM COATED in 1 BOTTLE (53489-400-02) |
| Marketing Start Date | 1988-12-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b70731df-fead-4f40-941e-7889a9c5d800 Details
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:
Nystatin tablets are provided for oral administration as coated tablets containing 500,000 units nystatin.
Inactive ingredients: anhydrous lactose, carnauba wax, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, and titanium dioxide.
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.
INDICATIONS AND USAGE
CONTRAINDICATIONS
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.
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.
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.
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
HOW SUPPLIED
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| NYSTATIN
nystatin tablet, film coated |
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| Labeler - Sun Pharmaceutical Industries, Inc. (146974886) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Frontida BioPharm Inc. | 080243260 | MANUFACTURE(53489-400) , ANALYSIS(53489-400) , PACK(53489-400) | |