Quick answers
- What is Infliximab-dyyb used for?
- The FDA-approved label (Zymfentra, CELLTRION USA Inc., August 18, 2026) says: “ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ZYMFENTRA is indicated in adults for maintenance treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Infliximab-dyyb have a boxed warning?
- Yes. The FDA label for Zymfentra has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Infliximab-dyyb?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Infliximab-dyyb been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Infliximab-dyyb?
- 1 company lists prescription products of Infliximab-dyyb in the FDA NDC Directory, including CELLTRION USA, Inc..
What Infliximab-dyyb is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ZYMFENTRA is indicated in adults for maintenance treatment of …
— FDA label: Zymfentra, CELLTRION USA Inc., effective August 18, 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.
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 →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Zymfentra |
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.
- CELLTRION USA, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761358 ZYMFENTRA | Celltrion | October 20, 2023 | 1, latest February 22, 2024 2024: Manufacturing (CMC) |
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) — Zymfentra, CELLTRION USA Inc., effective August 18, 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 →