everolimus
- Product NDC
- 59651-931
- 11-digit product format
- 596510931
- Labeler code
- 59651
- Product ID
- 59651-931_43ef3c29-0e25-4fdd-aea1-06a20af9bbab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- everolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA219533
- Marketing category
- ANDA
- Marketing start
- 2026-02-25
- Substance
- EVEROLIMUS
- Active strength
- .25 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
- everolimus
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EVEROLIMUS | .25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9HW64Q8G6G |
| Rxcui | 977427, 977434, 977438, 2056895 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-931-60 | everolimus | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-931-60 | 59651093160 | 60 TABLET in 1 BOTTLE (59651-931-60) | 60 tablet | 2026-02-25 | No | No | Historical |