Nystatin
- Product NDC
- 62135-813
- 11-digit product format
- 621350813
- Labeler code
- 62135
- Product ID
- 62135-813_4c47b825-6b93-307f-e063-6394a90a2b7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- NDA050299
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1971-04-14
- Substance
- NYSTATIN
- Active strength
- 100000 U/mL
- Pharmacologic classes
- Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nystatin
- Listing expiration
- 2027-12-31
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 |
|---|
| 62135-813-46 | Nystatin | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 7 |
| 62135-813-47 | Nystatin | 473 mL in 1 BOTTLE | SUSPENSION | 473 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-813 | NYSTATIN SUSPENSION [CHARTWELL RX, LLC] | 5 | Current NDC, 2 package rows | 20250327_9954118e-abe6-4388-98c9-4473d39b2e28.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 |
|---|
| 62135-813-46 | 62135081346 | 60 mL in 1 BOTTLE (62135-813-46) | 60 ml | 2024-06-27 | No | No | Current |
| 62135-813-47 | 62135081347 | 473 mL in 1 BOTTLE (62135-813-47) | 473 ml | 2024-04-10 | No | No | Current |