Nystatin
- Product NDC
- 68071-3911
- 11-digit product format
- 680713911
- Labeler code
- 68071
- Product ID
- 68071-3911_42f2113b-4399-d2bb-e063-6394a90a7cb7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin Cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA061966
- Marketing category
- ANDA
- Marketing start
- 2015-04-01
- 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 |
|---|
| 68071-3911-5 | Nystatin | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 68071-3911-5 | Nystatin | 15 g in 1 TUBE | CREAM | 15 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3911-5 | 68071391105 | 1 TUBE in 1 CARTON (68071-3911-5) / 15 g in 1 TUBE | 1 tube | 2025-11-06 | No | No | Current |