Lenalidomide
- Product NDC
- 0378-1935
- 11-digit product format
- 003781935
- Labeler code
- 0378
- Product ID
- 0378-1935_3d041421-9aaf-4f7a-b5e2-b75899dc03c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA213912
- Marketing category
- ANDA
- Marketing start
- 2022-09-06
- Substance
- LENALIDOMIDE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Thalidomide Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lenalidomide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LENALIDOMIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F0P408N6V4 |
| Rxcui | 602910, 602912, 643712, 643720, 1242231, 1428947 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-1935-01 | Lenalidomide | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 4 |
| 0378-1935-28 | Lenalidomide | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-1935 | LENALIDOMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20231114_76f6c1e7-985b-43d9-892c-849df50ae80e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-1935-01 | 00378193501 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01) | 100 capsule | 2023-03-07 | No | No | Current |
| 0378-1935-28 | 00378193528 | 28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28) | 28 capsule | 2023-03-07 | No | No | Current |