Quick answers
- What is Lenalidomide used for?
- The FDA-approved label (Revlimid, Celgene Corporation, March 24, 2023) says: “REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: • Multiple myeloma (MM), in combination with dexamethasone. • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lenalidomide have a boxed warning?
- Yes. The FDA label for Revlimid has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lenalidomide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lenalidomide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lenalidomide?
- 19 companies list prescription products of Lenalidomide in the FDA NDC Directory, including Accord Healthcare Inc., Camber Pharmaceuticals, Inc. and Alvogen Inc..
What Lenalidomide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: • Multiple myeloma (MM), in combination with dexamethasone. • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). …
— FDA label: Revlimid, Celgene Corporation, effective March 24, 2023. Read the full label on DailyMed →
The FDA has 17 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
15 of 17 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 114 in the FDA NDC Directory |
| Brand names | Revlimid |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Accord Healthcare Inc.6 products
- Camber Pharmaceuticals, Inc.6 products
- Alvogen Inc.6 products
- Aurobindo Pharma Limited6 products
- Cipla USA Inc.6 products
- Zydus Pharmaceuticals USA Inc.6 products
- Novugen Pharma (USA) LLC6 products
- Dr. Reddy's Laboratories Inc.6 products
- Celgene Corporation6 products
- Amneal Pharmaceuticals NY LLC6 products
- Sun Pharmaceutical Industries, Inc.6 products
- Mylan Pharmaceuticals Inc.6 products
- Zydus Lifesciences Limited6 products
- Teva Pharmaceuticals, Inc.6 products
- Devatis, Inc.6 products
- Padagis US LLC6 products
- Exelan Pharmaceuticals Inc.6 products
- Apotex Corp.6 products
- Biocon Pharma Inc.6 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021880 REVLIMID | Bristol Myers Squibb | December 27, 2005 | 38, latest July 22, 2026 2026: Labeling · 2026: REMS · 2023: REMS |
Generic approvals (17)
- ANDA201452Arrow Intl · May 21, 2021
- ANDA209348DR Reddys · October 14, 2021
- ANDA211022Apotex · August 30, 2022
- ANDA213912Mylan · August 30, 2022
- ANDA210480Alvogen · August 31, 2022
- ANDA210435Cipla · September 6, 2022
- ANDA210154Zydus Pharms · September 12, 2022
- ANDA211846Sun Pharm · February 8, 2023
- ANDA213885Eugia Pharma · March 6, 2023
- ANDA214618Cipla · March 6, 2023
- ANDA212414Hetero Labs Ltd V · May 11, 2023
- ANDA217265Qilu · February 22, 2024
- ANDA217281Novugen · September 11, 2024
- ANDA216213Amneal · January 31, 2025
- ANDA215759Biocon Pharma · March 3, 2025
- ANDA217554Deva Holding As · May 22, 2025
- ANDA218872Accord Hlthcare · November 14, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Revlimid, Celgene Corporation, effective March 24, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →