Everolimus
- Product NDC
- 51991-379
- 11-digit product format
- 519910379
- Labeler code
- 51991
- Product ID
- 51991-379_e7f5ef4d-6763-4908-9b64-c2a2f600b2c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus tablets
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA205432
- Marketing category
- ANDA
- Marketing start
- 2021-05-21
- 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 |
|---|
| 51991-379-06 | Everolimus | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 51991-379-60 | Everolimus | 60 in 1 CARTON | TABLET | 60 | | 8 |
| 51991-379-99 | Everolimus | 10 in 1 BLISTER PACK | TABLET | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-379 | EVEROLIMUS (EVEROLIMUS TABLETS) TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240328_c7bb6ba1-9a7f-43f5-b058-ef26d4b59221.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 |
|---|
| 51991-379-06 | 51991037906 | 60 TABLET in 1 BOTTLE (51991-379-06) | 60 tablet | 2023-03-13 | | No | No | Current |
| 51991-379-60 | 51991037960 | 60 BLISTER PACK in 1 CARTON (51991-379-60) / 10 TABLET in 1 BLISTER PACK (51991-379-99) | 60 blister pack | 2021-05-21 | 0000-00-00 | No | No | Current |
| 51991-379-99 | 51991037999 | 10 in 1 BLISTER PACK | | | | | | Historical |