Nystatin and Triamcinolone Acetonide
- Product NDC
- 53002-9360
- 11-digit product format
- 530029360
- Labeler code
- 53002
- Product ID
- 53002-9360_e62215be-cd16-464f-82d2-88c971414fa0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin and Triamcinolone Acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA062364
- Marketing category
- ANDA
- Marketing start
- 1987-12-22
- Marketing end
- 0000-00-00
- Substance
- NYSTATIN; TRIAMCINOLONE ACETONIDE
- Active strength
- 100000 [USP'U]/g; mg/g
- Pharmacologic classes
- Polyene Antifungal [EPC],Polyenes [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-9360-1 | 2025-01-30 | C162847 | 48780-1 | f386c649-a9e8-0266-e053-dadaa90a7c1a | Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP |
| 53002-9360-2 | 2025-01-30 | C162847 | 48780-1 | f386c649-a9e8-0266-e053-dadaa90a7c1a | Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP |
| 53002-9360-1 | 2023-06-07 | C162847 | 48780-1 | f386c649-a9e8-0266-e053-dadaa90a7c1a | Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP |
| 53002-9360-2 | 2023-06-07 | C162847 | 48780-1 | f386c649-a9e8-0266-e053-dadaa90a7c1a | Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP |
| 53002-9360-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-a9e8-0266-e053-dadaa90a7c1a | Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP |
| 53002-9360-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-a9e8-0266-e053-dadaa90a7c1a | Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-9360-1 | Nystatin and Triamcinolone Acetonide | 15 g in 1 TUBE | CREAM | 15 | | 4 |
| 53002-9360-2 | Nystatin and Triamcinolone Acetonide | 30 g in 1 TUBE | CREAM | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-9360 | NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [RPK PHARMACEUTICALS, INC.] | 4 | Legacy NDC, 2 package rows | 20230609_e935821e-4e1b-4b5c-b943-5332c0b7a76b.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 |
|---|
| 53002-9360-1 | 53002936001 | 15 g in 1 TUBE (53002-9360-1) | 15 g | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-9360-2 | 53002936002 | 30 g in 1 TUBE (53002-9360-2) | 30 g | 2021-01-01 | 0000-00-00 | No | No | Current |