TORPENZ
- Product NDC
- 0245-0823
- 11-digit product format
- 002450823
- Labeler code
- 0245
- Product ID
- 0245-0823_4ad25f33-f7a7-4d57-9c5a-7dcea62f27b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA214182
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- Substance
- EVEROLIMUS
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TORPENZ
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EVEROLIMUS | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9HW64Q8G6G |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0245-0823-04 | TORPENZ | 28 in 1 CARTON | TABLET | 28 | | 11 |
| 0245-0823-30 | TORPENZ | 30 in 1 BOTTLE | TABLET | 30 | | 11 |
| 0245-0823-89 | TORPENZ | 1 in 1 BLISTER PACK | TABLET | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0245-0823 | TORPENZ (EVEROLIMUS) TABLET [UPSHER-SMITH LABORATORIES, LLC] | 9 | Current NDC, 3 package rows | 20241120_4c0075dd-a0a8-4dc4-be32-1be8383fbbdc.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 |
|---|
| 0245-0823-04 | 00245082304 | 28 BLISTER PACK in 1 CARTON (0245-0823-04) / 1 TABLET in 1 BLISTER PACK (0245-0823-89) | 28 blister pack | 2025-10-21 | No | No | Historical |
| 0245-0823-30 | 00245082330 | 30 TABLET in 1 BOTTLE (0245-0823-30) | 30 tablet | 2024-06-24 | No | No | Historical |
| 0245-0823-89 | 00245082389 | 1 in 1 BLISTER PACK | | | | | Historical |