NYSTATIN
- Product NDC
- 63629-8520
- 11-digit product format
- 636298520
- Labeler code
- 63629
- Product ID
- 63629-8520_e505ff47-c84a-4e72-a249-5232d13f216d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NYSTATIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA062832
- Marketing category
- ANDA
- Marketing start
- 2020-08-14
- 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 |
|---|
| 63629-8520-1 | NYSTATIN | 473 mL in 1 BOTTLE | SUSPENSION | 473 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8520 | NYSTATIN SUSPENSION [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 1 package rows | 20230127_b06c65cd-5b65-4bc6-aae9-b9381c6f1948.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 |
|---|
| 63629-8520-1 | 63629852001 | 473 mL in 1 BOTTLE (63629-8520-1) | 473 ml | 2021-05-19 | 0000-00-00 | No | No | Current |