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NDC 69315-0504-60 NYSTATIN 100000 [USP'U]/mL Details
NYSTATIN 100000 [USP'U]/mL
NYSTATIN is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Leading Pharma, LLC. 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: 69315-0504-60Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Nystatin
Product Information
| NDC | 69315-0504 |
|---|---|
| Product ID | 69315-504_65730b91-5b22-4bfa-a3ca-13f12c7a2eed |
| Associated GPIs | |
| GCN Sequence Number | 009537 |
| GCN Sequence Number Description | nystatin ORAL SUSP 100000/ML ORAL |
| HIC3 | W3A |
| HIC3 Description | ANTIFUNGAL ANTIBIOTICS |
| GCN | 42440 |
| 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 | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 100000 |
| Active Ingredient Units | [USP'U]/mL |
| Substance Name | NYSTATIN |
| Labeler Name | Leading Pharma, LLC |
| Pharmaceutical Class | Polyene Antifungal [EPC], Polyenes [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214346 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 69315-0504-60 (69315050460)
| NDC Package Code | 69315-504-60 |
|---|---|
| Billing NDC | 69315050460 |
| Package | 1 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLE |
| Marketing Start Date | 2022-12-05 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.1195 |
| Pricing Unit | ML |
| Effective Date | 2024-01-17 |
| NDC Description | NYSTATIN 100,000 UNIT/ML SUSP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis