Quick answers
- What is Lofexidine hydrochloride used for?
- The FDA-approved label (Lucemyra, BioCorRx Pharmaceuticals Inc, July 22, 2026) says: “LUCEMYRA is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. LUCEMYRA is a central alpha-2 adrenergic agonist indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lofexidine hydrochloride have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lofexidine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lofexidine hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lofexidine hydrochloride?
- 7 companies list prescription products of Lofexidine hydrochloride in the FDA NDC Directory, including BioCorRx Pharmaceuticals Inc, Prasco Laboratories and Novadoz Pharmaceuticals LLC.
What Lofexidine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LUCEMYRA is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. LUCEMYRA is a central alpha-2 adrenergic agonist indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.
— FDA label: Lucemyra, BioCorRx Pharmaceuticals Inc, effective July 22, 2026. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Lucemyra |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| lofexidine hydrochloride 0.18 mg tablet | Generic | $7.39 per tablet |
| lofexidine hydrochloride 0.18 mg tablet, coated | Generic | $7.39 per tablet |
| lofexidine hydrochloride 0.2 mg tablet, film coated | Generic | $7.39 per tablet |
| lofexidine hydrochloride 0.2 mg tablet, film coated | Brand: Lucemyra | $23.22 per tablet |
NADAC list of November 4, 2026; these prices took effect between November 19, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- BioCorRx Pharmaceuticals Inc2 products
- Prasco Laboratories1 product
- Novadoz Pharmaceuticals LLC1 product
- Uswm, LLC1 product
- ANI Pharmaceuticals, Inc.1 product
- Florida Pharmaceutical Products, LLC1 product
- Indoco Remedies Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209229 LUCEMYRA | Biocorrx Pharms | May 16, 2018 | 1, latest September 5, 2024 2024: Labeling |
Generic approvals (3)
- ANDA218613Regcon Holdings · August 20, 2024
- ANDA218699Msn · February 24, 2025
- ANDA219917Novitium Pharma · October 22, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2046591, 2046597 |
|---|---|
| SPL set ID of the quoted label | 0a848cc2-4dda-40d9-8b01-d789fe8981ed |
| FDA labels (SPL) | 7 |
| FDA applications | NDA209229, 3 ANDA |
| Active ingredients (FDA) | LOFEXIDINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lucemyra, BioCorRx Pharmaceuticals Inc, effective July 22, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →