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NDC 60505-4533-01 Lenalidomide 5 mg/1 Details
Lenalidomide 5 mg/1
Lenalidomide is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is LENALIDOMIDE.
MedlinePlus Drug Summary
Lenalidomide is used to treat a certain type of myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Lenalidomide is also used along with dexamethasone to treat people with multiple myeloma (a type of cancer of the bone marrow). It is also used to treat people with multiple myeloma after a hematopoietic stem-cell transplant (HSCT; procedure in which certain blood cells are removed from the body and then returned to the body). Lenalidomide is also used to treat people with mantle cell lymphoma (a fast-growing cancer that begins in the cells of the immune system) who have been treated with bortezomib (Velcade) and at least one other medication. Lenalidomide should not be used to treat people with chronic lymphocytic leukemia (a type of cancer of the white blood cells that gets worse slowly over time) unless they are participating in a clinical trial (research study to see whether a medication may be used safely and effectively to treat a certain condition). Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.
Related Packages: 60505-4533-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lenalidomide
Product Information
| NDC | 60505-4533 |
|---|---|
| Product ID | 60505-4533_d0acaa12-91f3-f88f-ddf5-036e57dfc05c |
| Associated GPIs | |
| GCN Sequence Number | 060230 |
| GCN Sequence Number Description | lenalidomide CAPSULE 5 MG ORAL |
| HIC3 | V1M |
| HIC3 Description | ANTINEOPLASTIC IMMUNOMODULATOR AGENTS |
| GCN | 26314 |
| HICL Sequence Number | 033412 |
| HICL Sequence Number Description | LENALIDOMIDE |
| Brand/Generic | Generic |
| Proprietary Name | Lenalidomide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lenalidomide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | LENALIDOMIDE |
| Labeler Name | Apotex Corp. |
| Pharmaceutical Class | Thalidomide Analog [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211022 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 60505-4533-01 (60505453301)
| NDC Package Code | 60505-4533-1 |
|---|---|
| Billing NDC | 60505453301 |
| Package | 100 CAPSULE in 1 BOTTLE (60505-4533-1) |
| Marketing Start Date | 2022-09-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |