Drug company (FDA labeler)
CivicaScript LLC
NDC labeler code: 82249
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
- TemozolomideTemodar · 6 products
- EverolimusYulithira, Zortress, Afinitor · 4 products
- DroxidopaNorthera · 3 products
- Dimethyl fumarateTecfidera · 2 products
- Abiraterone acetateZytiga, Abirtega, Yonsa · 2 products
- CapecitabineXeloda · 2 products
- DalfampridineAmpyra · 1 product
- FingolimodGilenya · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 5, 2021 | ANDA205426 | Everolimus EVEROLIMUS | Breckenridge |
| February 18, 2021 | ANDA213911 | Droxidopa DROXIDOPA | Alkem Labs Ltd |
| December 30, 2020 | ANDA208004 | Fingolimod FINGOLIMOD HYDROCHLORIDE | Alkem Labs Ltd |
| September 24, 2020 | ANDA210440 | Dimethyl fumarate DIMETHYL FUMARATE | Alkem Labs Ltd |
| October 31, 2018 | ANDA208339 | Abiraterone acetate ABIRATERONE ACETATE | Hikma |
| July 30, 2018 | ANDA206765 | Dalfampridine DALFAMPRIDINE | Alkem Labs Ltd |
| November 27, 2017 | ANDA207652 | Capecitabine XORIDRONO | Alkem Labs Ltd |
| April 26, 2017 | ANDA207658 | Temozolomide TEMOZOLOMIDE | Deva Holding As |
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.
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