Everolimus
- Product NDC
- 0093-7769
- 11-digit product format
- 000937769
- Labeler code
- 0093
- Product ID
- 0093-7769_aa521933-950a-441b-9146-93e479a4dde7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA210050
- Marketing category
- ANDA
- Marketing start
- 2023-10-23
- Marketing end
- 2026-09-30
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Everolimus
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EVEROLIMUS | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9HW64Q8G6G |
| Rxcui | 845507, 845515, 998189, 1119400 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-7769-19 | Everolimus | 1 in 1 BLISTER PACK | TABLET | 1 | | 10 |
| 0093-7769-24 | Everolimus | 28 in 1 CARTON | TABLET | 28 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-7769 | EVEROLIMUS TABLET [TEVA PHARMACEUTICALS USA, INC.] | 8 | Current NDC, 2 package rows | 20250216_e3bca36b-29ed-4a2b-a1be-a57b6af805f6.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 |
|---|
| 0093-7769-19 | 00093776919 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 0093-7769-24 | 00093776924 | 28 BLISTER PACK in 1 CARTON (0093-7769-24) / 1 TABLET in 1 BLISTER PACK (0093-7769-19) | 28 blister pack | 2023-10-23 | 2026-09-30 | No | No | Historical |