Drug

Who makes lofexidine?

3 companies list lofexidine as a human prescription drug. Forms: tablet; tablet, coated. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing lofexidine

CompanyFormsApplicationNDCsRegistered sites
Indoco Remedies LimitedIndiatablet, coatedANDAANDA21861317
ANI Pharmaceuticals, Inc.United StatestabletANDAANDA21991711
Florida Pharmaceutical Products LLCUnited Statestablet, coatedANDAANDA21861311
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Common questions

Who makes lofexidine?
3 companies list lofexidine as a human prescription drug in the openFDA NDC Directory, led by Indoco Remedies Limited, ANI Pharmaceuticals, Inc., Florida Pharmaceutical Products LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic lofexidine?
3 companies list lofexidine under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.