Lenalidomide
- Product NDC
- 16729-695
- 11-digit product format
- 167290695
- Labeler code
- 16729
- Product ID
- 16729-695_513e8d33-e9bf-df2b-e063-6394a90a1ee9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA218872
- Marketing category
- ANDA
- Marketing start
- 2026-03-02
- Substance
- LENALIDOMIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Thalidomide Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lenalidomide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LENALIDOMIDE | 15 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F0P408N6V4 |
| Rxcui | 602910, 602912, 643712, 643720, 1242231, 1428947 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba3b6b9d-cf27-aec0-3395-500a538c6915 | Product name | 6 | 20260306 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16729-695-06 | Lenalidomide | 21 in 1 BOTTLE | CAPSULE | 21 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-695-06 | EA - Each | 16729-695 | ad75c588-3eb0-4efb-b6c2-86e3e70c152a | 1 | 2026-03-17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 602910 | lenalidomide 10 MG Oral Capsule | PSN | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 643712 | lenalidomide 15 MG Oral Capsule | PSN | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 1242231 | lenalidomide 2.5 MG Oral Capsule | PSN | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 1428947 | lenalidomide 20 MG Oral Capsule | PSN | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 643720 | lenalidomide 25 MG Oral Capsule | PSN | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 602912 | lenalidomide 5 MG Oral Capsule | PSN | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 602910 | lenalidomide 10 MG Oral Capsule | SCD | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 643712 | lenalidomide 15 MG Oral Capsule | SCD | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 1242231 | lenalidomide 2.5 MG Oral Capsule | SCD | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 1428947 | lenalidomide 20 MG Oral Capsule | SCD | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 643720 | lenalidomide 25 MG Oral Capsule | SCD | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
| 602912 | lenalidomide 5 MG Oral Capsule | SCD | 9c414531-a3bf-455a-aca7-9e716f42099a | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16729-695-06 | 16729069506 | 21 CAPSULE in 1 BOTTLE (16729-695-06) | 21 capsule | 2026-03-02 | No | No | Current |