everolimus
- Product NDC
- 0378-3099
- 11-digit product format
- 003783099
- Labeler code
- 0378
- Product ID
- 0378-3099_d51ed68d-10ee-4bbc-9c97-869744f060dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- everolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA212936
- Marketing category
- ANDA
- Marketing start
- 2022-12-15
- Marketing end
- 0000-00-00
- Substance
- EVEROLIMUS
- Active strength
- 10 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-3099-85 | 00378309985 | 4 BLISTER PACK in 1 CARTON (0378-3099-85) > 7 TABLET in 1 BLISTER PACK (0378-3099-32) | 4 blister pack | 2022-12-15 | 0000-00-00 | No | No | Current |