Nystatin
- Product NDC
- 60687-800
- 11-digit product format
- 606870800
- Labeler code
- 60687
- Product ID
- 60687-800_11ff6ced-6e23-9aa1-e063-6294a90a7c04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA203621
- Marketing category
- ANDA
- Marketing start
- 2024-02-26
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'U]/mL
- Pharmacologic classes
- Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nystatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NYSTATIN | 100000 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 312055 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-800-17 | Nystatin | 10 in 1 CASE | SUSPENSION | 10 | | 1 |
| 60687-800-40 | Nystatin | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 1 |
| 60687-800-46 | Nystatin | 10 in 1 TRAY | SUSPENSION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-800 | NYSTATIN SUSPENSION [AMERICAN HEALTH PACKAGING] | 1 | Current NDC, 3 package rows | 20240228_d8c251a6-d4da-4664-bff4-6868541d1178.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-800-17 | 60687080017 | 10 TRAY in 1 CASE (60687-800-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-800-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-800-40) | 10 tray | 2024-02-26 | No | No | Current |
| 60687-800-40 | 60687080040 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 60687-800-46 | 60687080046 | 10 in 1 TRAY | | | | | Historical |