Everolimus
- Product NDC
- 63850-0059
- 11-digit product format
- 638500059
- Labeler code
- 63850
- Product ID
- 63850-0059_6df3819e-2d45-4030-a4af-6caeccb8a471
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Natco Pharma Limited
- Application
- ANDA205426
- Marketing category
- ANDA
- Marketing start
- 2021-03-05
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Everolimus
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EVEROLIMUS | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9HW64Q8G6G |
| Rxcui | 845507, 845515, 998189, 1119400 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63850-0059-1 | Everolimus | 4 in 1 CARTON | TABLET | 4 | | 7 |
| 63850-0059-1 | Everolimus | 7 in 1 BLISTER PACK | TABLET | 7 | | 7 |
| 63850-0059-4 | Everolimus | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63850-0059 | EVEROLIMUS TABLET [NATCO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 3 package rows | 20230609_e3dbbc24-7e55-4069-a305-e2cded2db641.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 |
|---|
| 63850-0059-1 | 63850005901 | 4 BLISTER PACK in 1 CARTON (63850-0059-1) / 7 TABLET in 1 BLISTER PACK | 4 blister pack | 2021-03-05 | 0000-00-00 | No | No | Current |
| 63850-0059-4 | 63850005904 | 30 TABLET in 1 BOTTLE (63850-0059-4) | 30 tablet | 2023-05-26 | | No | No | Historical |