Active ingredient
Lenalidomide
114 finished FDA listings contain Lenalidomide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LENALIDOMIDE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 19
- Strengths listed
- 10 mg/1 · 15 mg/1 · 2.5 mg/1 · 20 mg/1 · 25 mg/1 · 5 mg/1
- Brand names in FDA listings
- Revlimid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 342369
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021880 | BRISTOL MYERS SQUIBB | 2005-12-27 | 6 |
| ANDA 201452 | ARROW INTL | 2021-05-21 | 6 |
| ANDA 209348 | DR REDDYS | 2021-10-14 | 6 |
| ANDA 213912 | MYLAN | 2022-08-30 | 6 |
| ANDA 211022 | APOTEX | 2022-08-30 | 6 |
| ANDA 210480 | ALVOGEN | 2022-08-31 | 6 |
| ANDA 210435 | CIPLA | 2022-09-06 | 10 |
| ANDA 210154 | ZYDUS PHARMS | 2022-09-12 | 12 |
| ANDA 211846 | SUN PHARM | 2023-02-08 | 6 |
| ANDA 214618 | CIPLA | 2023-03-06 | 2 |
| ANDA 213885 | EUGIA PHARMA | 2023-03-06 | 6 |
| ANDA 212414 | HETERO LABS LTD V | 2023-05-11 | 6 |
| ANDA 217265 | QILU | 2024-02-22 | 6 |
| ANDA 217281 | NOVUGEN | 2024-09-11 | 6 |
| ANDA 216213 | AMNEAL | 2025-01-31 | 6 |
| ANDA 215759 | BIOCON PHARMA | 2025-03-03 | 6 |
| ANDA 217554 | DEVA HOLDING AS | 2025-05-22 | 6 |
| ANDA 218872 | ACCORD HLTHCARE | 2025-11-14 | 6 |
Official labeling on DailyMed
- REVLIMID (LENALIDOMIDE) CAPSULE [CELGENE CORPORATION] · version 41 · 2026-08-06
- LENALIDOMIDE CAPSULE [TEVA PHARMACEUTICALS, INC.] · version 6 · 2026-06-11
- LENALIDOMIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] · version 6 · 2026-05-20
- LENALIDOMIDE CAPSULE [ACCORD HEALTHCARE INC.] · version 6 · 2026-05-11
- LENALIDOMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] · version 4 · 2026-03-23
- LENALIDOMIDE CAPSULE [DEVATIS INC.] · version 2 · 2026-02-05
- LENALIDOMIDE CAPSULE [PADAGIS US LLC] · version 1 · 2026-02-02
- LENALIDOMIDE CAPSULE [NOVUGEN PHARMA (USA) LLC] · version 1 · 2026-01-06
- LENALIDOMIDE CAPSULE [ALVOGEN, INC.] · version 4 · 2025-11-17
- LENALIDOMIDE CAPSULE [BIOCON PHARMA INC.,] · version 9 · 2025-03-06
- LENALIDOMIDE CAPSULE [CIPLA USA INC.] · version 6 · 2025-01-06
- LENALIDOMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 6 · 2024-12-16
Showing the 12 most recent of 20 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.