Nystatin
- Product NDC
- 63629-8694
- 11-digit product format
- 636298694
- Labeler code
- 63629
- Product ID
- 63629-8694_9579a03c-ea5a-40fc-b908-bc876c88d6f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA062225
- Marketing category
- ANDA
- Marketing start
- 2006-09-21
- 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 | 543546 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8694-1 | Nystatin | 15 g in 1 TUBE | CREAM | 15 | | 105 |
| 63629-8694-1 | Nystatin | 1 in 1 CARTON | CREAM | 1 | | 105 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8694 | NYSTATIN CREAM [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 2 package rows | 20240502_840eebe8-5de2-40c5-acfd-03a98b2e790e.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 |
|---|
| 63629-8694-1 | 63629869401 | 1 TUBE in 1 CARTON (63629-8694-1) / 15 g in 1 TUBE | 1 tube | 2007-01-25 | 0000-00-00 | No | No | Current |