Nystatin and Triamcinolone Acetonide
- Product NDC
- 0316-0223
- 11-digit product format
- 003160223
- Labeler code
- 0316
- Product ID
- 0316-0223_483437cb-feeb-0aa8-e063-6294a90a5c4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin and Triamcinolone Acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Crown Laboratories
- Application
- ANDA207730
- Marketing category
- ANDA
- Marketing start
- 2018-01-02
- Substance
- NYSTATIN; TRIAMCINOLONE ACETONIDE
- Active strength
- 100000; 1 [USP'U]/g; mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nystatin and Triamcinolone Acetonide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NYSTATIN | 100000 [USP'U]/g |
| TRIAMCINOLONE ACETONIDE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E, F446C597KA |
| Rxcui | 1053753 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0316-0223-15 | Nystatin and Triamcinolone Acetonide | 15 g in 1 TUBE | CREAM | 15 | | 10 |
| 0316-0223-15 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | | 10 |
| 0316-0223-30 | Nystatin and Triamcinolone Acetonide | 30 g in 1 TUBE | CREAM | 30 | | 10 |
| 0316-0223-30 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | | 10 |
| 0316-0223-60 | Nystatin and Triamcinolone Acetonide | 60 g in 1 TUBE | CREAM | 60 | | 10 |
| 0316-0223-60 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0316-0223 | NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [CROWN LABORATORIES] | 8 | Current NDC, Legacy NDC, 6 package rows | 20231025_54aae5d3-e482-4da0-a1b2-0ed70e6c2915.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 |
|---|
| 0316-0223-15 | 00316022315 | 1 TUBE in 1 CARTON (0316-0223-15) / 15 g in 1 TUBE | 1 tube | 2018-01-02 | 0000-00-00 | No | No | Current |
| 0316-0223-30 | 00316022330 | 1 TUBE in 1 CARTON (0316-0223-30) / 30 g in 1 TUBE | 1 tube | 2018-01-02 | 0000-00-00 | No | No | Current |
| 0316-0223-60 | 00316022360 | 1 TUBE in 1 CARTON (0316-0223-60) / 60 g in 1 TUBE | 1 tube | 2018-01-02 | 0000-00-00 | No | No | Current |