NYSTATIN
- Product NDC
- 69315-307
- 11-digit product format
- 693150307
- Labeler code
- 69315
- Product ID
- 69315-307_520822eb-a9f1-4017-9a73-1979ee53f4e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NYSTATIN
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA209082
- Marketing category
- ANDA
- Marketing start
- 2019-08-19
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'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 [USP'U]/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 884308 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-307-15 | NYSTATIN | 15 g in 1 TUBE | OINTMENT | 15 | | 5 |
| 69315-307-15 | NYSTATIN | 1 in 1 CARTON | OINTMENT | 1 | | 5 |
| 69315-307-30 | NYSTATIN | 30 g in 1 TUBE | OINTMENT | 30 | | 5 |
| 69315-307-30 | NYSTATIN | 1 in 1 CARTON | OINTMENT | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-307 | NYSTATIN OINTMENT [LEADING PHARMA, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20191009_8900ba02-2c6a-4dd4-b82f-45620c06e255.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69315-307-15 | 69315030715 | 1 TUBE in 1 CARTON (69315-307-15) / 15 g in 1 TUBE | 1 tube | 2019-08-19 | 0000-00-00 | No | No | Current |
| 69315-307-30 | 69315030730 | 1 TUBE in 1 CARTON (69315-307-30) / 30 g in 1 TUBE | 1 tube | 2019-08-19 | 0000-00-00 | No | No | Current |