Lenalidomide
- Product NDC
- 60505-4536
- 11-digit product format
- 605054536
- Labeler code
- 60505
- Product ID
- 60505-4536_0ac7ca79-cd31-4bc1-ddc6-a90c9efcc1c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA211022
- Marketing category
- ANDA
- Marketing start
- 2023-03-09
- 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 |
|---|
| 60505-4536-1 | Lenalidomide | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
| 60505-4536-2 | Lenalidomide | 21 in 1 BOTTLE | CAPSULE | 21 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-4536 | LENALIDOMIDE CAPSULE [APOTEX CORP.] | 5 | Current NDC, 2 package rows | 20240704_9943e098-20b0-dbb3-af12-7816eedd3f70.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 |
|---|
| 60505-4536-1 | 60505453601 | 100 in 1 BOTTLE | | | | | Historical |
| 60505-4536-2 | 60505453602 | 21 CAPSULE in 1 BOTTLE (60505-4536-2) | 21 capsule | 2023-03-09 | No | No | Current |