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NDC 69315-0306-15 NYSTATIN 100000 1/g Details
NYSTATIN 100000 1/g
NYSTATIN is a TOPICAL POWDER in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Leading Pharma, LLC. The primary component is NYSTATIN.
MedlinePlus Drug Summary
Topical nystatin is used to treat fungal infections of the skin. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.
Related Packages: 69315-0306-15Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nystatin Topical
Product Information
| NDC | 69315-0306 |
|---|---|
| Product ID | 69315-306_537f7da0-c60f-4c3f-9f74-ce5bd49dddc6 |
| Associated GPIs | 90150080002920 |
| GCN Sequence Number | 007284 |
| GCN Sequence Number Description | nystatin POWDER 100000/G TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 30160 |
| 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 | POWDER |
| Route | TOPICAL |
| Active Ingredient Strength | 100000 |
| Active Ingredient Units | 1/g |
| Substance Name | NYSTATIN |
| Labeler Name | Leading Pharma, LLC |
| Pharmaceutical Class | Polyene Antifungal [EPC], Polyenes [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208838 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69315-0306-15 (69315030615)
| NDC Package Code | 69315-306-15 |
|---|---|
| Billing NDC | 69315030615 |
| Package | 15 g in 1 BOTTLE, PLASTIC (69315-306-15) |
| Marketing Start Date | 2018-04-23 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.3688 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | NYSTATIN 100,000 UNIT/GM POWD |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 089e6444-2bd1-443e-acf0-dfeaa69faef9 Details
DESCRIPTION
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1.
Structural formula:
Nystatin topical powder is for dermatologic use.
Nystatin topical powder contains 100,000 nystatin units per gram dispersed in talc.
CLINCAL PHARMACOLOGY
Pharmacokinetics
Nystatin is not absorbed from intact skin or mucous membrane.
Microbiology
Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.
Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.
Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
INDICATIONS AND USAGE
CONTRAINDICATIONS
PRECAUTIONS
General
Nystatin topical powder should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.
If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens
INFORMATION FOR THE PATIENT
Patients using this medication should receive the following information and instructions:
1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.
2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.
Laboratory Tests
If there is lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.
Pregnancy
Teratogenic Effects
Category C
Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical powder should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
Nursing Mothers
It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
Pediatric Use
Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION).
Geriatric Use
Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
ADVERSE REACTIONS
The frequency of adverse events reported in patients using nystatin topical powder is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS, General).
DOSAGE AND ADMINISTRATION
Very moist lesions are best treated with the topical dusting powder.
Adults and Pediatric Patients (Neonates and Older)
Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.
HOW SUPPLIED
Nystatin topical powder is supplied as 100,000 units nystatin per gram in plastic squeeze bottles:
15g (NDC 69315-306-15)
30g (NDC 69315-306-30)
60g (NDC 69315-306-60)
STORAGE
Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F).
Keep tightly closed.
Manufactured for:
Leading Pharma LLC, Fairfield, NJ 07004
Manufactured by:
Lyne Laboratories, Inc. Brockton, MA 02301
R0-06/17
INGREDIENTS AND APPEARANCE
| NYSTATIN
nystatin powder |
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| Labeler - Leading Pharma, LLC (079575060) |
| Registrant - Lyne Laboratories, Inc (053510459) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Lyne Laboratories, Inc | 053510459 | manufacture(69315-306) | |