Nystatin
- Product NDC
- 68071-2556
- 11-digit product format
- 680712556
- Labeler code
- 68071
- Product ID
- 68071-2556_2dcc540d-ce8e-d0a7-e063-6294a90a646c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA064022
- Marketing category
- ANDA
- Marketing start
- 1993-01-28
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-2556-5 | 2025-02-10 | C162847 | 48780-1 | f386c649-e6e9-0266-e053-dadaa90a7c1a | Nystatin Cream USP, 100,000 units per gram |
| 68071-2556-5 | 2025-01-30 | C162847 | 48780-1 | f386c649-e6e9-0266-e053-dadaa90a7c1a | Nystatin Cream USP, 100,000 units per gram |
| 68071-2556-5 | 2023-07-17 | C162847 | 48780-1 | f386c649-e6e9-0266-e053-dadaa90a7c1a | Nystatin Cream USP, 100,000 units per gram |
| 68071-2556-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-e6e9-0266-e053-dadaa90a7c1a | Nystatin Cream USP, 100,000 units per gram |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2556-5 | Nystatin | 15 g in 1 TUBE | CREAM | 15 | | 3 |
| 68071-2556-5 | Nystatin | 1 in 1 CARTON | CREAM | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2556 | NYSTATIN CREAM [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250212_cf6b7c68-7769-1808-e053-2995a90aa426.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 |
|---|
| 68071-2556-5 | 68071255605 | 1 TUBE in 1 CARTON (68071-2556-5) / 15 g in 1 TUBE | 1 tube | 2021-10-28 | 0000-00-00 | No | No | Current |