LENALIDOMIDE
- Product NDC
- 60219-1716
- 11-digit product format
- 602191716
- Labeler code
- 60219
- Product ID
- 60219-1716_85e664d1-1d56-4b9b-b2a1-96b32b5b1a7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA216213
- Marketing category
- ANDA
- Marketing start
- 2025-02-12
- Substance
- LENALIDOMIDE
- Active strength
- 10 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 | 10 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 |
|---|
| 60219-1716-1 | LENALIDOMIDE | 28 in 1 BOTTLE | CAPSULE | 28 | | 6 |
| 60219-1716-2 | LENALIDOMIDE | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-1716 | LENALIDOMIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] | 5 | Current NDC, 2 package rows | 20250214_da7b5dda-79ed-4c4a-88aa-52394fdc7c54.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 |
|---|
| 60219-1716-1 | 60219171601 | 28 CAPSULE in 1 BOTTLE (60219-1716-1) | 28 capsule | 2025-02-12 | No | No | Current |
| 60219-1716-2 | 60219171602 | 100 CAPSULE in 1 BOTTLE (60219-1716-2) | 100 capsule | 2025-02-12 | No | No | Current |