FDA Orange Book
Generic for Lucemyra
Lucemyra contains lofexidine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Lucemyra is lofexidine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lucemyra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 0.18MG BASE | Marketed (Rx) | AB | 3 | AB |
NDA 209229, held by BIOCORRX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lofexidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| REGCON HOLDINGS LLC | 218613 | AB (A-rated, therapeutically equivalent) | August 20, 2024 | EQ 0.18MG BASE |
| MSN LABORATORIES PRIVATE LTD | 218699 | AB (A-rated, therapeutically equivalent) | February 24, 2025 | EQ 0.18MG BASE |
| NOVITIUM PHARMA LLC | 219917 | AB (A-rated, therapeutically equivalent) | October 22, 2025 | EQ 0.18MG BASE |
Lucemyra NDC codes
Questions
Is there a generic for Lucemyra?
Yes. The generic name for Lucemyra is lofexidine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Lucemyra?
The active ingredient in Lucemyra is lofexidine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.