Quick answers
- What is Clofazimine used for?
- The FDA-approved label (Lamprene, Novartis Pharmaceuticals Corporation, August 17, 2026) says: “LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clofazimine have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Clofazimine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clofazimine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Clofazimine?
- 1 company lists prescription products of Clofazimine in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation.
What Clofazimine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy. …
— FDA label: Lamprene, Novartis Pharmaceuticals Corporation, effective August 17, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Capsule, liquid filled |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Lamprene |
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.
- Novartis Pharmaceuticals Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019500 LAMPRENE | Novartis | December 15, 1986 | 12, latest January 31, 2019 2019: Labeling · 2016: Labeling · 2003: Labeling |
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
| RxCUI (RxNorm) | 197521, 206062 |
|---|---|
| SPL set ID of the quoted label | 2e07448f-f888-4747-80ab-570c1b621250 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA019500 |
| Active ingredients (FDA) | CLOFAZIMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lamprene, Novartis Pharmaceuticals Corporation, effective August 17, 2026; 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 →