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 4 of 59 · 1,173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC3e5e9975-6f36-42e4-ab46-0e75dda835922026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1662285
unii: ISQ9I6J12J
LinezolidLINEZOLIDMylan Pharmaceuticals Inc.83a84897-ccca-42a1-ab1a-bbf1d43a982b2026-07-09Warnings, Adverse reactionsExact identifier
unii: ISQ9I6J12J
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
LinezolidLINEZOLIDSportpharm LLC7368298b-d75c-4950-bbc1-00fc53f472ec2026-07-02Warnings, Adverse reactionsExact identifier
unii: ISQ9I6J12J
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC6e70e63b-bfd5-478d-a8ee-8ba22c9efabd2026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 1662285
unii: ISQ9I6J12J

Reported adverse events (FAERS/openFDA)#

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