Lenalidomide
- Product NDC
- 63304-042
- 11-digit product format
- 633040042
- Labeler code
- 63304
- Product ID
- 63304-042_2922537e-47de-b6b9-e063-6294a90a0f19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA211846
- Marketing category
- ANDA
- Marketing start
- 2023-03-04
- Substance
- LENALIDOMIDE
- Active strength
- 5 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 | 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 |
|---|
| 63304-042-01 | Lenalidomide | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
| 63304-042-27 | Lenalidomide | 28 in 1 BOTTLE | CAPSULE | 28 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-042 | LENALIDOMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 6 | Current NDC, 2 package rows | 20241215_84d9dec7-9250-4dbd-9a0d-23e75f111892.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 |
|---|
| 63304-042-01 | 63304004201 | 100 CAPSULE in 1 BOTTLE (63304-042-01) | 100 capsule | 2023-03-04 | No | No | Current |
| 63304-042-27 | 63304004227 | 28 CAPSULE in 1 BOTTLE (63304-042-27) | 28 capsule | 2023-03-04 | No | No | Current |