Everolimus
- Product NDC
- 51991-991
- 11-digit product format
- 519910991
- Labeler code
- 51991
- Product ID
- 51991-991_fade73fb-a367-4c53-83dd-1352c3ad807b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA217640
- Marketing category
- ANDA
- Marketing start
- 2025-01-28
- Substance
- EVEROLIMUS
- Active strength
- 3 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9HW64Q8G6G |
| Rxcui | 845507, 845515, 998189, 1119400, 1308428, 1308430, 1308432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51991-991-28 | Everolimus | 4 in 1 CARTON | TABLET, FOR SUSPENSION | 4 | | 20 |
| 51991-991-77 | Everolimus | 28 in 1 BOTTLE | TABLET, FOR SUSPENSION | 28 | | 20 |
| 51991-991-99 | Everolimus | 7 in 1 BLISTER PACK | TABLET, FOR SUSPENSION | 7 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-991 | EVEROLIMUS TABLET EVEROLIMUS TABLET, FOR SUSPENSION [BRECKENRIDGE PHARMACEUTICAL, INC.] | 16 | Current NDC, 3 package rows | 20250130_01f7b5fb-be0d-4adf-acd2-6899018de966.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 |
|---|
| 51991-991-28 | 51991099128 | 4 BLISTER PACK in 1 CARTON (51991-991-28) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (51991-991-99) | 4 blister pack | 2025-01-28 | No | No | Historical |
| 51991-991-77 | 51991099177 | 28 TABLET, FOR SUSPENSION in 1 BOTTLE (51991-991-77) | | 2025-07-31 | No | No | Historical |
| 51991-991-99 | 51991099199 | 7 in 1 BLISTER PACK | | | | | Historical |