Nystatin and Triamcinolone Acetonide
- Product NDC
- 46708-606
- 11-digit product format
- 467080606
- Labeler code
- 46708
- Product ID
- 46708-606_e15b0fea-44bd-4c3d-a436-c72038dd1792
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin and Triamcinolone Acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA214090
- Marketing category
- ANDA
- Marketing start
- 2025-04-08
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nystatin and Triamcinolone Acetonide
- Listing expiration
- 2026-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-606-15 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 46708-606-15 | Nystatin and Triamcinolone Acetonide | 15 g in 1 TUBE | CREAM | 15 | | 1 |
| 46708-606-30 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 46708-606-30 | Nystatin and Triamcinolone Acetonide | 30 g in 1 TUBE | CREAM | 30 | | 1 |
| 46708-606-60 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 46708-606-60 | Nystatin and Triamcinolone Acetonide | 60 g in 1 TUBE | CREAM | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-606 | NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 6 package rows | 20250410_51966a3b-dc09-4f41-941f-0f9247974d88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-606-15 | 46708060615 | 1 TUBE in 1 CARTON (46708-606-15) / 15 g in 1 TUBE | 1 tube | 2025-04-08 | No | No | Historical |
| 46708-606-30 | 46708060630 | 1 TUBE in 1 CARTON (46708-606-30) / 30 g in 1 TUBE | 1 tube | 2025-04-08 | No | No | Historical |
| 46708-606-60 | 46708060660 | 1 TUBE in 1 CARTON (46708-606-60) / 60 g in 1 TUBE | 1 tube | 2025-04-08 | No | No | Historical |