nystatin
- Product NDC
- 68788-8690
- 11-digit product format
- 687888690
- Labeler code
- 68788
- Product ID
- 68788-8690_77d6819e-b284-42b7-af0b-ccf75793d70a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nystatin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA062474
- Marketing category
- ANDA
- Marketing start
- 2024-06-07
- Substance
- NYSTATIN
- Active strength
- 500000 [USP'U]/1
- 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 | 500000 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 312059 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8690-1 | nystatin | 120 in 1 BOTTLE | TABLET, COATED | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8690 | NYSTATIN TABLET, COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20240616_197e3046-3e58-4246-b260-f3995dce41a1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8690-1 | 68788869001 | 120 TABLET, COATED in 1 BOTTLE (68788-8690-1) | 2024-06-07 | No | No | Historical |