Prescription medicine
Daratumumab Brand names: Darzalex
Daratumumab (Darzalex) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the daratumumab FDA label on DailyMed (effective September 8, 2026, Janssen Biotech, Inc.); the BLA 761036 record on Drugs@FDA; every daratumumab label on DailyMed.
Highlights of the record
FDA label of September 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
Forms and strengths
- 100 mg/5ml
Injection (solution) (concentrate).
On the market
- Earliest approval on file
- November 16, 2015 Darzalex, Janssen Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
What is daratumumab used for?
From the label: indications and usageDARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. in combination with bortezomib and dexamethasone in patients who have received at least one […]
Conditions named in the indications of daratumumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD38-directed Cytolytic Antibody.
Source: FDA drug label (Darzalex IV), Janssen Biotech, Inc., effective September 8, 2026 (SPL set a4d0efe9-5e54-467e-9eb4-56fa7d53b60b), via openFDA; the full label on DailyMed
Is there a generic for daratumumab (Darzalex)?
No generic daratumumab is approved (Drugs@FDA, October 8, 2026).
- 2015 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has daratumumab been recalled?
The FDA's Enforcement Report lists 1 recall naming daratumumab since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the daratumumab label say about other medicines?
The daratumumab label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name daratumumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lenalidomide | warnings and precautions | The combination of DARZALEX with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. |
| Pomalidomide | warnings and precautions | The combination of DARZALEX with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. |
| Thalidomide | warnings and precautions | The combination of DARZALEX with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. |
Other labels that name daratumumab
Source: FDA drug label (Darzalex IV), Janssen Biotech, Inc., effective September 8, 2026 (SPL set a4d0efe9-5e54-467e-9eb4-56fa7d53b60b), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as daratumumab?
36 other medicines are given the same way (intravenous) and in the same FDA class as daratumumab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Isatuximab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as daratumumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to daratumumab
- 36 medicines for the same use
- Other cd38-directed cytolytic antibodys
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other