LENALIDOMIDE
- Product NDC
- 60219-1717
- 11-digit product format
- 602191717
- Labeler code
- 60219
- Product ID
- 60219-1717_85e664d1-1d56-4b9b-b2a1-96b32b5b1a7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA216213
- Marketing category
- ANDA
- Marketing start
- 2025-02-12
- 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
openFDA Listing Details
- Product ID
- 60219-1717_85e664d1-1d56-4b9b-b2a1-96b32b5b1a7e
- SPL ID
- 85e664d1-1d56-4b9b-b2a1-96b32b5b1a7e
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- LENALIDOMIDE
- Generic name
- lenalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2025-02-12
- Marketing category
- ANDA
- Application number
- ANDA216213
- Pharmacologic classes
- Thalidomide Analog [EPC]
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LENALIDOMIDE | 15 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | F0P408N6V4 |
| Rxcui | 602910, 602912, 643712, 643720, 1242231, 1428947 |
| Spl Set Id | da7b5dda-79ed-4c4a-88aa-52394fdc7c54 |
| Manufacturer Name | Amneal Pharmaceuticals NY LLC |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 60219-1717-1 | 21 CAPSULE in 1 BOTTLE (60219-1717-1) | 2025-02-12 | No |
| 60219-1717-2 | 100 CAPSULE in 1 BOTTLE (60219-1717-2) | 2025-02-12 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| F0P408N6V4 | LENALIDOMIDE | 191732-72-6 | LENALIDOMIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-1717-1 | 60219171701 | 21 CAPSULE in 1 BOTTLE (60219-1717-1) | 21 capsule | 2025-02-12 | No | No | Historical |
| 60219-1717-2 | 60219171702 | 100 CAPSULE in 1 BOTTLE (60219-1717-2) | 100 capsule | 2025-02-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| LENALIDOMIDE | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited | 2026-05-14 | HUMAN PRESCRIPTION DRUG LABEL | 6 |