Everolimus
- Product NDC
- 0054-0497
- 11-digit product format
- 000540497
- Labeler code
- 0054
- Product ID
- 0054-0497_7558b1b9-ed53-4abc-8a08-194c945bb00f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Everolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA207486
- Marketing category
- ANDA
- Marketing start
- 2020-06-08
- Substance
- EVEROLIMUS
- Active strength
- 7.5 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
- 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 | 7.5 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 |
|---|
| 0054-0497-13 | Everolimus | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 0054-0497-14 | Everolimus | 1 in 1 CARTON | TABLET | 1 | | 9 |
| 0054-0497-14 | Everolimus | 28 in 1 BLISTER PACK | TABLET | 28 | | 9 |
| 0054-0497-22 | Everolimus | 90 in 1 BOTTLE | TABLET | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0497 | EVEROLIMUS TABLET [HIKMA PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20231221_5aaf2fb7-93f6-40d6-941a-9583a3794ce7.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 |
|---|
| 0054-0497-13 | 00054049713 | 30 TABLET in 1 BOTTLE (0054-0497-13) | 30 tablet | 2021-02-12 | 0000-00-00 | No | No | Current |
| 0054-0497-14 | 00054049714 | 1 BLISTER PACK in 1 CARTON (0054-0497-14) > 28 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-06-08 | 0000-00-00 | No | No | Current |
| 0054-0497-22 | 00054049722 | 90 in 1 BOTTLE | | | | | | Historical |