NYSTATIN
- Product NDC
- 81033-015
- 11-digit product format
- 810330015
- Labeler code
- 81033
- Product ID
- 81033-015_45b08d8c-c755-d45b-e063-6394a90aa4c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NYSTATIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Kesin Pharma Corporation
- Application
- ANDA062832
- Marketing category
- ANDA
- Marketing start
- 2020-08-14
- Substance
- NYSTATIN
- Active strength
- 100000 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 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 |
|---|
| 81033-015-01 | NYSTATIN | 100 in 1 CASE | SUSPENSION | 100 | | 2 |
| 81033-015-05 | NYSTATIN | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 2 |
| 81033-015-54 | NYSTATIN | 50 in 1 CARTON | SUSPENSION | 50 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81033-015-01 | 81033001501 | 100 CUP, UNIT-DOSE in 1 CASE (81033-015-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05) | | 2025-11-24 | No | No | Current |
| 81033-015-05 | 81033001505 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 81033-015-54 | 81033001554 | 50 CUP, UNIT-DOSE in 1 CARTON (81033-015-54) / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05) | | 2025-11-24 | No | No | Current |