LENALIDOMIDE
- Product NDC
- 70771-1677
- 11-digit product format
- 707711677
- Labeler code
- 70771
- Product ID
- 70771-1677_b85844ee-03a3-407f-97a9-ae0098212923
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LENALIDOMIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA210154
- Marketing category
- ANDA
- Marketing start
- 2022-09-12
- 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 |
|---|
| 70771-1677-1 | LENALIDOMIDE | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 70771-1677-7 | LENALIDOMIDE | 28 in 1 BOTTLE | CAPSULE | 28 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1677 | LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.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 |
|---|
| 70771-1677-1 | 70771167701 | 100 CAPSULE in 1 BOTTLE (70771-1677-1) | 100 capsule | 2022-09-12 | 0000-00-00 | No | No | Current |
| 70771-1677-7 | 70771167707 | 28 CAPSULE in 1 BOTTLE (70771-1677-7) | 28 capsule | 2022-09-12 | 0000-00-00 | No | No | Current |