FDA.reportPublic FDA data

NDC 0409-4883-03 - Linezolid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0409-4883
Requested NDC
0409-4883-03
Package NDCs from labels
0409-4883-11, 0409-4883-01, 0409-4883-03, 0409-4883-10
Manufacturer
Hospira, Inc. | Pfizer Asia Manufacturing Pte Ltd
Effective date
2026-06-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Linezolid - Hospira, Inc. | Pfizer Asia Manufacturing Pte LtdHospira, Inc. | Pfizer Asia Manufacturing Pte Ltd2026-06-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4883-01Linezolid1 in 1 POUCHINJECTION, SOLUTION120
0409-4883-01Linezolid10 in 1 CASEINJECTION, SOLUTION1020
0409-4883-03Linezolid300 mL in 1 BAGINJECTION, SOLUTION30020
0409-4883-10Linezolid10 in 1 CASEINJECTION, SOLUTION1020
0409-4883-10Linezolid1 in 1 POUCHINJECTION, SOLUTION120
0409-4883-11Linezolid300 mL in 1 BAGINJECTION, SOLUTION30020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4883LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]18Current NDC, Legacy NDC, 6 package rows20250508_c401f1a8-cc37-461b-bfef-f2e156629bf8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4883-01ML - Milliliter0409-4883950fb9a1-2a9a-484b-a68d-eb0f335ce70a12015-07-20
0409-4883-03ML - Milliliter0409-4883f18c2e38-3b0f-455b-a255-2ba9e35b28a512023-07-06
0409-4883-10ML - Milliliter0409-48835412bfdc-08bd-455f-8a08-5f01a02cf1cd12023-07-06
0409-4883-11ML - Milliliter0409-488310a830b7-4c1d-4a69-9a37-81a3ab78b18112019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LINEZOLIDACTIVE INGREDIENTISQ9I6J12JLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
LINEZOLIDACTIVE MOIETYISQ9I6J12JLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 59 · 1,173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 451W47IQ8X
LinezolidLINEZOLIDSun Pharmaceutical Industries, Inc.870c9600-04d5-4b44-a5b5-02252a310f222026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1662285
unii: ISQ9I6J12J
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
LinezolidLINEZOLIDMacleods Pharmaceuticals Limited90dd8c13-c428-4472-91e5-5b1fcdc4fce32026-07-15Warnings, Adverse reactionsExact identifier
unii: ISQ9I6J12J
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LinezolidLINEZOLIDHikma Pharmaceuticals USA Inc.16007ca5-7956-4414-af38-406a6623400e2026-07-15Warnings, Adverse reactionsExact identifier
unii: ISQ9I6J12J
LinezolidLINEZOLIDEugia US LLCb721756c-3b5e-456d-a2f6-0d8a56cc7f352026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 1662285
unii: ISQ9I6J12J

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.