Everolimus
- Product NDC
- 70954-775
- 11-digit product format
- 709540775
- Labeler code
- 70954
- Product ID
- 70954-775_ed7f01b0-3660-4785-a057-a32eea78d64b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA220597
- Marketing category
- ANDA
- Marketing start
- 2025-10-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Everolimus
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EVEROLIMUS | 5 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-775-20 | 70954077520 | 28 BLISTER PACK in 1 CARTON (70954-775-20) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70954-775-10) | 28 blister pack | 2025-10-10 | No | No | Current |