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NDC 63629-8521-01 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 Bryant Ranch Prepack. 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: 63629-8521-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nystatin
Product Information
| NDC | 63629-8521 |
|---|---|
| Product ID | 63629-8521_c6b8c132-c241-4768-99a3-fec1c71f1fdd |
| Associated GPIs | 88100010001805 |
| 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 | Bryant Ranch Prepack |
| Pharmaceutical Class | Polyene Antifungal [EPC], Polyenes [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA065422 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 63629-8521-01 (63629852101)
| NDC Package Code | 63629-8521-1 |
|---|---|
| Billing NDC | 63629852101 |
| Package | 60 mL in 1 BOTTLE (63629-8521-1) |
| Marketing Start Date | 2021-05-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |