Zyvox

Product NDC
66298-5140
11-digit product format
662985140
Labeler code
66298
Product ID
66298-5140_19883774-59a8-7251-e063-6294a90a3f5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hp Halden Pharma AS
Application
NDA021131
Marketing category
NDA
Marketing start
2018-06-05
Substance
LINEZOLID
Active strength
600 mg/300mL
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zyvox
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINEZOLID600 mg/300mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J
Rxcui1662285, 1662286

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66298-5140-1Zyvox300 mL in 1 BAGINJECTION, SOLUTION3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66298-5140ZYVOX (LINEZOLID) INJECTION, SOLUTION [HP HALDEN PHARMA AS]4Current NDC, Legacy NDC, 1 package rows20240530_efe6818c-b798-4d1d-8196-6447a305ad71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662285linezolid 600 MG in 300 ML InjectionPSNefe6818c-b798-4d1d-8196-6447a305ad714
1662286ZYVOX 600 MG in 300 ML InjectionPSNefe6818c-b798-4d1d-8196-6447a305ad714
1662286300 ML linezolid 2 MG/ML Injection [Zyvox]SBDefe6818c-b798-4d1d-8196-6447a305ad714
1662285300 ML linezolid 2 MG/ML InjectionSCDefe6818c-b798-4d1d-8196-6447a305ad714
1662286300 ML Zyvox 2 MG/ML InjectionSYefe6818c-b798-4d1d-8196-6447a305ad714
1662285linezolid 600 MG per 300 ML InjectionSYefe6818c-b798-4d1d-8196-6447a305ad714
1662286Zyvox 600 MG per 300 ML InjectionSYefe6818c-b798-4d1d-8196-6447a305ad714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66298-5140-166298514001300 mL in 1 BAG (66298-5140-1) 300 ml2018-06-050000-00-00NoNoCurrent