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Active ingredient

Linezolid

40 finished FDA listings contain Linezolid as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
LINEZOLID
Dosage forms
Granule, For Suspension, Injection, Injection, Solution, Powder, For Suspension, Suspension, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
27
Strengths listed
100 mg/5ml · 2 mg/ml · 200 mg/100ml · 600 mg/1 · 600 mg/300ml
Brand names in FDA listings
Zyvox

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 190376

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
NDA 021131PFIZER2000-04-185
NDA 021132PFIZER2000-04-182
NDA 021130PFIZER2000-04-181
ANDA 200068HIKMA2015-06-031
NDA 206473HOSPIRA2015-06-181
ANDA 200904SANDOZ2015-07-162
ANDA 205517ALKEM LABS LTD2015-12-216
ANDA 204239HETERO LABS LTD V2015-12-214
ANDA 205233ALEMBIC2015-12-212
ANDA 078845RISING2015-12-212
ANDA 204764FRESENIUS KABI USA2016-03-152
ANDA 206917EUGIA PHARMA2016-08-041
ANDA 207526NOVEL LABS INC2016-08-221
ANDA 207354NANG KUANG PHARM CO2016-12-202
ANDA 207001HQ SPCLT PHARMA2017-07-072
ANDA 210702CHARTWELL RX2019-04-251
ANDA 206454HIKMA2022-08-221
ANDA 211813HETERO LABS2022-10-312
ANDA 210378MACLEODS PHARMS2024-10-101
ANDA 219558CAPLIN2025-12-081

Official labeling on DailyMed

Showing the 12 most recent of 36 labels.

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