Lenalidomide
- Product NDC
- 43598-511
- 11-digit product format
- 435980511
- Labeler code
- 43598
- Product ID
- 43598-511_023f2dc9-b878-9d13-44d0-894310c6b8da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA209348
- Marketing category
- ANDA
- Marketing start
- 2022-09-07
- 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 |
|---|
| 43598-511-01 | Lenalidomide | 100 in 1 BOTTLE | CAPSULE | 100 | | 21 |
| 43598-511-63 | Lenalidomide | 28 in 1 BOTTLE | CAPSULE | 28 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-511 | LENALIDOMIDE CAPSULE [DR. REDDY'S LABORATORIES INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20230902_ca8cc2cc-c856-e676-4f60-1e46d7b53d73.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 |
|---|
| 43598-511-01 | 43598051101 | 100 CAPSULE in 1 BOTTLE (43598-511-01) | 100 capsule | 2022-09-07 | 0000-00-00 | No | No | Current |
| 43598-511-63 | 43598051163 | 28 CAPSULE in 1 BOTTLE (43598-511-63) | 28 capsule | 2022-09-07 | 0000-00-00 | No | No | Current |