NYSTATIN
- Product NDC
- 68071-3543
- 11-digit product format
- 680713543
- Labeler code
- 68071
- Product ID
- 68071-3543_2ad1d4c2-cbc9-0304-e063-6394a90aae6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NYSTATIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA214346
- Marketing category
- ANDA
- Marketing start
- 2022-12-05
- 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 |
|---|
| 68071-3543-6 | NYSTATIN | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 2 |
| 68071-3543-6 | NYSTATIN | 1 in 1 PACKAGE | SUSPENSION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3543 | NYSTATIN SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20250105_0b4dfd5e-641e-40e9-e063-6294a90a3fda.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 |
|---|
| 68071-3543-6 | 68071354306 | 1 BOTTLE in 1 PACKAGE (68071-3543-6) / 60 mL in 1 BOTTLE | 1 bottle | 2023-11-29 | No | No | Historical |