Medicine
Lofexidine 0.18 mg tablet
Lofexidine 0.18 mg tablet is a generic prescription medicine for oral use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store in original container at controlled room temperature, 25°C (77°F), with…
Key facts
- Active ingredient (INN)
- Lofexidine
- Brand
- Sold under the generic name
- Strength
- 0.18 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle, 36 tablets, 96 tablets and 3 more
- Manufacturers
- Indoco RemediesIndiaANI PharmaceuticalsFlorida Pharmaceutical Products
- Origin register
- US FDA, United States
- Storage
- Store in original container at controlled room temperature, 25°C (77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07BC04 Lofexidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 August 2024
- Identifiers
- RxCUI 2046591DailyMed set ID ce4488e2-842c-45ba-aca7-075a900e2a1c, 335e26bf-b236-46d6-81cf-2879e5f3b1d9, ed7613f5-ac52-4108-afb7-d92c818d6e3cNDC 71921-250, 70954-909, 14445-146Application ANDA218613, ANDA219917
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 36 tablet, coated in 1 bottle | 14445-146-36 | Indoco RemediesIndia | 21 August 2024 |
| 1 bottle in 1 carton / 96 tablet, coated in 1 bottle | 14445-146-96 | Indoco RemediesIndia | 21 August 2024 |
| 36 tablet in 1 bottle | 70954-909-10 | ANI Pharmaceuticals | 22 October 2025 |
| 96 tablet in 1 bottle | 70954-909-20 | ANI Pharmaceuticals | 22 October 2025 |
| 1 bottle in 1 carton / 36 tablet, coated in 1 bottle | 71921-250-36 | Florida Pharmaceutical Products | 21 August 2024 |
| 1 bottle in 1 carton / 96 tablet, coated in 1 bottle | 71921-250-96 | Florida Pharmaceutical Products | 21 August 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 16 May 2018 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Lofexidine
Clinical summary
Lofexidine is a prescription medicine indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. It is available as tablets for oral use. MedsAcross supplies Lofexidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LofexidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LOFEXIDINE prescribing information (BioCorRx Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Lofexidine 0.18 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.