NDC 0121-0868-05 - Nystatin
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0121-0868
- Requested NDC
- 0121-0868-05
- Package NDCs from labels
- 0121-0868-02, 0121-0868-16, 0121-0868-05, 0121-0868-40, 0121-0868-50, 0121-0868-00
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
- Effective date
- 2026-07-21
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Nystatin Oral Suspension USP [100,000 units per mL] | PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | 2026-07-21 | HUMAN PRESCRIPTION DRUG LABEL |
| Nystatin - Cardinal Health 107, LLC | Cardinal Health 107, LLC | 2026-02-26 | HUMAN PRESCRIPTION DRUG LABEL |
| Nystatin - RedPharm Drug | RedPharm Drug | 2024-07-25 | HUMAN PRESCRIPTION DRUG LABEL |
| Nystatin - American Health Packaging | American Health Packaging | 2024-02-22 | HUMAN PRESCRIPTION DRUG LABEL |
| Nystatin - A-S Medication Solutions | A-S Medication Solutions | 2023-10-19 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-0868-00 | Nystatin | 10 in 1 CASE | SUSPENSION | 10 | 8 | |
| 0121-0868-00 | Nystatin | 10 in 1 TRAY | SUSPENSION | 10 | 8 | |
| 0121-0868-02 | Nystatin | 60 mL in 1 BOTTLE, DROPPER | SUSPENSION | 60 | 8 | |
| 0121-0868-05 | Nystatin | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 8 | |
| 0121-0868-16 | Nystatin | 473 mL in 1 BOTTLE | SUSPENSION | 473 | 8 | |
| 0121-0868-40 | Nystatin | 4 in 1 CASE | SUSPENSION | 4 | 8 | |
| 0121-0868-40 | Nystatin | 10 in 1 TRAY | SUSPENSION | 10 | 8 | |
| 0121-0868-50 | Nystatin | 10 in 1 TRAY | SUSPENSION | 10 | 8 | |
| 0121-0868-50 | Nystatin | 5 in 1 CASE | SUSPENSION | 5 | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0868-00 | ML - Milliliter | 0121-0868 | b068ec19-d240-4824-a64e-273e938ce598 | 1 | 2020-08-06 |
| 0121-0868-02 | ML - Milliliter | 0121-0868 | 4ae76eca-a726-49f6-84c8-d8d6c9ee4765 | 1 | 2020-08-06 |
| 0121-0868-05 | ML - Milliliter | 0121-0868 | e2af12f7-3a29-4bd8-a874-d5e0c50d9a67 | 1 | 2020-08-06 |
| 0121-0868-16 | ML - Milliliter | 0121-0868 | f3d006ad-0cdc-4f80-983f-3450ba73191b | 1 | 2020-08-06 |
| 0121-0868-40 | ML - Milliliter | 0121-0868 | 831de8ef-a458-4bf3-94d7-fec8d021b6f4 | 1 | 2020-08-06 |
| 0121-0868-50 | ML - Milliliter | 0121-0868 | 2020f77a-6e92-4fc6-8c28-4e8675279aa3 | 1 | 2020-09-14 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.