Drug

Who makes imipenem and cilastatin sodium?

2 companies list imipenem and cilastatin sodium as a human prescription drug, including under the names PRIMAXIN IV. Forms: injection, powder, for 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 imipenem and cilastatin sodium

CompanyFormsApplicationNDCsRegistered sites
Fresenius Kabi USA, LLCUnited Statesinjection, powder, for solutionANDAANDA09057726
Merck Sharp & Dohme Corp.injection, powder, for solutionNDANDA05058710
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Common questions

Who makes imipenem and cilastatin sodium?
2 companies list imipenem and cilastatin sodium as a human prescription drug in the openFDA NDC Directory, led by Fresenius Kabi USA, LLC, Merck Sharp & Dohme Corp.. 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 PRIMAXIN IV?
1 company lists imipenem and cilastatin sodium 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.