Everolimus
- Product NDC
- 0378-0005
- 11-digit product format
- 003780005
- Labeler code
- 0378
- Product ID
- 0378-0005_73b397f2-f490-47e2-b253-8588fc664c0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA210130
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- Marketing end
- 0000-00-00
- Substance
- EVEROLIMUS
- Active strength
- 2 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0005 | EVEROLIMUS TABLET, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.] | 3 | Legacy NDC | 20231129_ca1a987e-f763-4026-93c5-c545ca95826c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0005-85 | 00378000585 | 4 BLISTER PACK in 1 CARTON (0378-0005-85) > 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK | 4 blister pack | 2021-10-01 | 0000-00-00 | No | No | Current |