Drug company (FDA labeler)
Concord Biotech Limited
Name in FDA records: CONCORD BIOTECH LIMITED
NDC labeler code: 68254
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- TacrolimusPrograf, Envarsus XR, Astagraf XL · 3 products
- TofacitinibXeljanz, Xeljanz XR · 2 products
- Mycophenolate mofetilCellcept, Myhibbin · 2 products
- Mycophenolic acidMyfortic · 2 products
- TeriflunomideAubagio · 2 products
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 9, 2026 | ANDA218821 | Tofacitinib TOFACITINIB CITRATE | Concord Biotech Ltd |
| April 7, 2025 | ANDA218663 | Teriflunomide TERIFLUNOMIDE | Neocubes Pharma |
| November 10, 2020 | ANDA213112 | Tacrolimus TACROLIMUS | Concord Biotech Ltd |
| July 31, 2020 | ANDA212087 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL | Concord Biotech Ltd |
| December 13, 2019 | ANDA211173 | Mycophenolic acid MYCOPHENOLATE SODIUM | Concord Biotech Ltd |
| January 8, 2019 | ANDA210181 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL | Concord Biotech Ltd |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- 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