Active ingredient
Infliximab
6 finished FDA listings contain Infliximab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- INFLIXIMAB, INFLIXIMAB-ABDA, INFLIXIMAB-DYYB, INFLIXIMAB-QBTX
- Dosage forms
- Injection, Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous, Subcutaneous
- Manufacturers / labelers
- 5
- Strengths listed
- 100 mg/1 · 100 mg/10ml · 120 mg/ml
- Brand names in FDA listings
- Avsola, Inflectra, Remicade, Renflexis, Zymfentra
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 191831
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 |
|---|---|---|---|
| BLA 103772 | CENTOCOR INC | 1998-08-24 | 2 |
| BLA 125544 | CELLTRION INC | 2016-04-05 | 1 |
| BLA 761054 | SAMSUNG BIOEPIS CO LTD | 2017-04-21 | 1 |
| BLA 761086 | AMGEN INC | 2019-12-06 | 1 |
| BLA 761358 | CELLTRION | 2023-10-20 | 1 |
Official labeling on DailyMed
- RENFLEXIS (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON LLC] · version 7 · 2026-09-01
- ZYMFENTRA (INFLIXIMAB-DYYB) KIT ZYMFENTRA (INFLIXIMAB-DYYB) INJECTION [CELLTRION USA INC.] · version 10 · 2026-08-20
- AVSOLA (INFLIXIMAB-AXXQ) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN, INC] · version 19 · 2026-07-29
- INFLECTRA (INFLIXIMAB-DYYB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] · version 24 · 2026-07-28
- INFLIXIMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] · version 5 · 2026-02-19
- REMICADE (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] · version 37 · 2025-06-05
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.