Drug

Who makes idarubicin hydrochloride?

3 companies list idarubicin hydrochloride as a human prescription drug, including under the names Idamycin PFS. Forms: injection, solution; solution. Routes: intravenous.

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 idarubicin hydrochloride

CompanyFormsApplicationNDCsRegistered sites
Hikma Pharmaceuticals USA Inc.United Statesinjection, solutionANDAANDA06527564
Meitheal Pharmaceuticals, Inc.injection, solutionANDAANDA06503630
Pfizer Laboratories Div Pfizer IncsolutionNDANDA05073430

Bulk ingredient listings

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Common questions

Who makes idarubicin hydrochloride?
3 companies list idarubicin hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., Meitheal Pharmaceuticals, Inc., Pfizer Laboratories Div Pfizer Inc. 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 Idamycin PFS?
2 companies list idarubicin hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies idarubicin hydrochloride active ingredient?
2 companies list idarubicin hydrochloride as a bulk ingredient, including Gemini PharmChem Mannheim GmbH, Olon USA LLC.