FDA.reportPublic FDA data

Linezolid

Product NDC
40032-022
11-digit product format
400320022
Labeler code
40032
Product ID
40032-022_66a60971-0fe7-42ea-833d-0b95bdae100f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207526
Marketing category
ANDA
Marketing start
2016-08-22
Marketing end
0000-00-00
Substance
LINEZOLID
Active strength
600 mg/1
Pharmacologic classes
Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-022-022023-01-30C16284748780-1f386c64a-3db1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval:2000
40032-022-052023-01-30C16284748780-1f386c64a-3db1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval:2000
40032-022-312023-01-30C16284748780-1f386c64a-3db1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval:2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-022-02Linezolid20 in 1 BOTTLETABLET202
40032-022-05Linezolid500 in 1 BOTTLETABLET5002
40032-022-30Linezolid10 in 1 BLISTER PACKTABLET102
40032-022-31Linezolid3 in 1 CARTONTABLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-022LINEZOLID TABLET [NOVEL LABORATORIES, INC.]2Legacy NDC, 4 package rows20191222_13990ee8-8fbe-402d-8aba-cba78964fd32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSN13990ee8-8fbe-402d-8aba-cba78964fd322
311347linezolid 600 MG Oral TabletSCD13990ee8-8fbe-402d-8aba-cba78964fd322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-022-024003200220220 TABLET in 1 BOTTLE (40032-022-02) 20 tablet2016-08-220000-00-00NoNoCurrent
40032-022-0540032002205500 TABLET in 1 BOTTLE (40032-022-05) 500 tablet2016-08-220000-00-00NoNoCurrent
40032-022-304003200223010 in 1 BLISTER PACKHistorical
40032-022-31400320022313 BLISTER PACK in 1 CARTON (40032-022-31) > 10 TABLET in 1 BLISTER PACK (40032-022-30) 3 blister pack2016-08-220000-00-00NoNoCurrent