Nystatin
- Product NDC
- 68788-8631
- 11-digit product format
- 687888631
- Labeler code
- 68788
- Product ID
- 68788-8631_efb3a87c-639a-4cd2-905a-73e79bd7778b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA212557
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- Substance
- NYSTATIN
- Active strength
- 100000 U/g
- 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/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 543546 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8631-1 | Nystatin | 15 g in 1 TUBE | CREAM | 15 | | 2 |
| 68788-8631-3 | Nystatin | 30 g in 1 TUBE | CREAM | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8631 | NYSTATIN CREAM [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20240420_d92f67a7-dcae-41c0-9a35-dbafa2361170.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 |
|---|
| 68788-8631-1 | 68788863101 | 15 g in 1 TUBE (68788-8631-1) | 15 g | 2024-04-15 | No | No | Historical |
| 68788-8631-3 | 68788863103 | 30 g in 1 TUBE (68788-8631-3) | 30 g | 2024-04-15 | No | No | Historical |