FDA.reportPublic FDA data

NDC 57664-683-31 - 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
57664-683
Requested NDC
57664-683-31
Package NDCs from labels
57664-683-31, 57664-683-57
Manufacturer
Sun Pharmaceutical Industries, Inc.
Effective date
2026-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Linezolid - Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc.2026-07-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-683-31Linezolid300 mL in 1 BAGINJECTION, SOLUTION30019
57664-683-57Linezolid10 in 1 BOXINJECTION, SOLUTION1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-683LINEZOLID INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]19Current NDC, Legacy NDC, 2 package rows20250221_870c9600-04d5-4b44-a5b5-02252a310f22.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-683-31ML - Milliliter57664-683cca028ae-e970-41bc-b307-e39aa792431412017-09-11
57664-683-57ML - Milliliter57664-6830b5a2567-f9b7-4cde-a5e8-fef439ffbf2a12017-09-11

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 2 of 14 · 262 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Infant DextroseDEXTROSEHenry Schein, Inc.ce71d929-d11e-444c-bd45-e025d51720572026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LinezolidLINEZOLIDEugia US LLCb721756c-3b5e-456d-a2f6-0d8a56cc7f352026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 1662285
unii: ISQ9I6J12J
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
LinezolidLINEZOLIDSportpharm LLC7368298b-d75c-4950-bbc1-00fc53f472ec2026-07-02Warnings, Adverse reactionsExact identifier
unii: ISQ9I6J12J
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: LX22YL083G
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: LX22YL083G
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEHospira, Inc.672264e3-9709-4bba-2a9d-12bf70c7396a2026-06-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC6e70e63b-bfd5-478d-a8ee-8ba22c9efabd2026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 1662278
rxcui: 1662285
unii: ISQ9I6J12J
LinezolidLINEZOLIDHospira, Inc.c401f1a8-cc37-461b-bfef-f2e156629bf82026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 1662285
unii: ISQ9I6J12J
LinezolidLINEZOLIDSandoz Inca287cdf4-47a8-459f-8890-86181af5e8362026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 1662278
rxcui: 1662285
unii: ISQ9I6J12J
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: B22547B95K
unii: LX22YL083G
LinezolidLINEZOLIDREMEDYREPACK INC.3e0d868d-f419-47e8-a3bc-41ececac468b2026-06-12Warnings, Adverse reactionsExact identifier
unii: ISQ9I6J12J
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEHospira, Inc.10e98cb0-31a5-4ad1-3eaa-aa4af387a42d2026-06-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: B22547B95K
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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