Everolimus
- Product NDC
- 63850-0062
- 11-digit product format
- 638500062
- Labeler code
- 63850
- Product ID
- 63850-0062_111c2e93-390f-40c6-a626-6aa45878a801
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Natco Pharma Limited
- Application
- ANDA205432
- Marketing category
- ANDA
- Marketing start
- 2021-05-20
- 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
- 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 | .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 |
|---|
| 63850-0062-2 | Everolimus | 6 in 1 CARTON | TABLET | 6 | | 5 |
| 63850-0062-3 | Everolimus | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
| 63850-0062-6 | Everolimus | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63850-0062 | EVEROLIMUS TABLET [NATCO PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 3 package rows | 20230609_d44998bb-5deb-4ee7-a0a5-979fe3f49557.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 |
|---|
| 63850-0062-2 | 63850006202 | 6 BLISTER PACK in 1 CARTON (63850-0062-2) / 10 TABLET in 1 BLISTER PACK (63850-0062-3) | 6 blister pack | 2021-05-20 | 0000-00-00 | No | No | Current |
| 63850-0062-3 | 63850006203 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 63850-0062-6 | 63850006206 | 60 TABLET in 1 BOTTLE (63850-0062-6) | 60 tablet | 2023-05-26 | | No | No | Historical |