Tolsura
- Product NDC
- 51862-462
- 11-digit product format
- 518620462
- Labeler code
- 51862
- Product ID
- 51862-462_2a3303f1-eee7-4c07-9532-e153be149369
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Itraconazole
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Mayne Pharma Commercial LLC
- Application
- NDA208901
- Marketing category
- NDA
- Marketing start
- 2018-12-11
- Substance
- ITRACONAZOLE
- Active strength
- 65 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tolsura
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ITRACONAZOLE | 65 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 304NUG5GF4 |
| Rxcui | 2106642, 2106648 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51862-462-08 | Tolsura | 8 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 8 | | 10 |
| 51862-462-60 | Tolsura | 60 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 60 | | 10 |
| 51862-462-88 | Tolsura | 8 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 8 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-462 | TOLSURA (ITRACONAZOLE) CAPSULE, GELATIN COATED [MAYNE PHARMA COMMERCIAL LLC] | 10 | Current NDC, Legacy NDC, 3 package rows | 20250425_306352d1-9d5a-49ad-b72d-893b99546861.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-462-08 | 51862046208 | 8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-08) | 2018-12-11 | 0000-00-00 | No | No | Current |
| 51862-462-60 | 51862046260 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60) | 2018-12-11 | 0000-00-00 | No | No | Current |
| 51862-462-88 | 51862046288 | 8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-88) | 2020-09-01 | 0000-00-00 | No | No | Current |