LENALIDOMIDE
- Product NDC
- 47781-487
- 11-digit product format
- 477810487
- Labeler code
- 47781
- Product ID
- 47781-487_1c3e5289-7ff0-54c1-9146-f7ec3f49aea2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alvogen, Inc.
- Application
- ANDA210480
- Marketing category
- ANDA
- Marketing start
- 2023-03-06
- Substance
- LENALIDOMIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Thalidomide Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LENALIDOMIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LENALIDOMIDE | 20 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 |
|---|
| 47781-487-01 | LENALIDOMIDE | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
| 47781-487-77 | LENALIDOMIDE | 21 in 1 BOTTLE | CAPSULE | 21 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47781-487 | LENALIDOMIDE CAPSULE [ALVOGEN, INC.] | 3 | Current NDC, 2 package rows | 20240606_adee5af1-c9ab-c0c7-e400-dea7d2a0d4be.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 |
|---|
| 47781-487-01 | 47781048701 | 100 CAPSULE in 1 BOTTLE (47781-487-01) | 100 capsule | 2023-03-06 | No | No | Current |
| 47781-487-77 | 47781048777 | 21 CAPSULE in 1 BOTTLE (47781-487-77) | 21 capsule | 2023-03-06 | No | No | Current |