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NDC 69315-0307-30 NYSTATIN 100000 [USP'U]/g Details
NYSTATIN 100000 [USP'U]/g
NYSTATIN is a TOPICAL OINTMENT 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: 69315-0307-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nystatin Topical
Product Information
| NDC | 69315-0307 |
|---|---|
| Product ID | 69315-307_520822eb-a9f1-4017-9a73-1979ee53f4e9 |
| Associated GPIs | 90150080004215 |
| GCN Sequence Number | 007283 |
| GCN Sequence Number Description | nystatin OINT. (G) 100000/G TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 30150 |
| 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 | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 100000 |
| Active Ingredient Units | [USP'U]/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 | ANDA209082 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69315-0307-30 (69315030730)
| NDC Package Code | 69315-307-30 |
|---|---|
| Billing NDC | 69315030730 |
| Package | 1 TUBE in 1 CARTON (69315-307-30) / 30 g in 1 TUBE |
| Marketing Start Date | 2019-08-19 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.27755 |
| Pricing Unit | GM |
| Effective Date | 2022-10-19 |
| NDC Description | NYSTATIN 100,000 UNIT/GM OINT |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-02 |
Standard Product Labeling (SPL)/Prescribing Information SPL 8900ba02-2c6a-4dd4-b82f-45620c06e255 Details
DESCRIPTION
Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei.
Structural formula:
Molecular Weight 926.13
Molecular Formula C47H75NO17
Nystatin Ointment is for dermatologic use. Nystatin Ointment for topical use contains
100,000 USP nystatin units per gram in a polyethylene and mineral oil base.
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 Ointment 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:
- The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.
- 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.
- 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 preparations 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).
ADVERSE REACTIONS
The frequency of adverse events reported in patients using Nystatin Ointment preparations 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).
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS.
YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Nystatin Ointment, USP (100,000 nystatin units per gram) is a yellow ointment available as follows:
NDC 69315-307-15 15 gram tube
NDC 69315-307-30 30 gram tube
STORAGE
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004
Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301
R0-12/17
INGREDIENTS AND APPEARANCE
| NYSTATIN
nystatin ointment |
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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(69315-307) | |