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Active ingredient

Fosfomycin

11 finished FDA listings contain Fosfomycin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FOSFOMYCIN SODIUM, FOSFOMYCIN TROMETHAMINE
Dosage forms
Granule, Granule, For Solution, Injection, Powder, For Solution, Powder
Routes
Intravenous, Oral
Manufacturers / labelers
10
Strengths listed
3 g/1 · 6 g/1
Brand names in FDA listings
Contepo, Fosfomycin Tromethamine

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4550

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 212548XIROMED2020-10-062
ANDA 214554ALKEM LABS LTD2021-10-213
ANDA 211881CIPLA2022-01-261
ANDA 216600AMNEAL2024-03-251
ANDA 217187PRECISION DOSE INC2025-06-031
NDA 212271MEITHEAL2025-10-221
ANDA 217608AUROBINDO PHARMA LTD2025-11-141
ANDA 217772AUCTA2026-04-091

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.