Active ingredient
Lofexidine
8 finished FDA listings contain Lofexidine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LOFEXIDINE HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- .18 mg/1 · .2 mg/1
- Brand names in FDA listings
- Lofexidine, Lucemyra
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 28863
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 |
|---|---|---|---|
| NDA 209229 | BIOCORRX PHARMS | 2018-05-16 | 4 |
| ANDA 218613 | REGCON HOLDINGS | 2024-08-20 | 2 |
| ANDA 218699 | MSN | 2025-02-24 | 1 |
| ANDA 219917 | NOVITIUM PHARMA | 2025-10-22 | 1 |
Official labeling on DailyMed
- LOFEXIDINE HYDROCHLORIDE TABLET, FILM COATED [PRASCO LABORATORIES] · version 4 · 2026-08-19
- LOFEXIDINE (LOFEXIDINE HYDROCHLORIDE) TABLET, FILM COATED [BIOCORRX PHARMACEUTICALS INC] · version 2 · 2026-08-17
- LUCEMYRA (LOFEXIDINE HYDROCHLORIDE) TABLET, FILM COATED [BIOCORRX PHARMACEUTICALS INC] · version 2 · 2026-08-17
- LUCEMYRA (LOFEXIDINE HYDROCHLORIDE) TABLET, FILM COATED [USWM, LLC] · version 10 · 2026-07-17
- LOFEXIDINE TABLET, COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] · version 3 · 2026-05-22
- LOFEXIDINE TABLET [ANI PHARMACEUTICALS, INC.] · version 1 · 2025-11-17
- LOFEXIDINE HYDROCHLORIDE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2025-03-10
- LOFEXIDINE TABLET, COATED [INDOCO REMEDIES LIMITED ] · version 3 · 2024-08-22
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.