Zyvox

Product NDC
66298-5137
11-digit product format
662985137
Labeler code
66298
Product ID
66298-5137_1988348c-3b04-2b38-e063-6394a90ada27
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
2018-06-04
Substance
LINEZOLID
Active strength
200 mg/100mL
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
LINEZOLID200 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J
Rxcui1662278, 1662280

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
66298-5137-1Zyvox100 mL in 1 BAGINJECTION, SOLUTION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66298-5137ZYVOX (LINEZOLID) INJECTION, SOLUTION [HP HALDEN PHARMA AS]4Current NDC, Legacy NDC, 1 package rows20240530_ce57225b-4580-442b-8c48-8045297cbb50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662278linezolid 200 MG in 100 ML InjectionPSNce57225b-4580-442b-8c48-8045297cbb504
1662280ZYVOX 200 MG in 100 ML InjectionPSNce57225b-4580-442b-8c48-8045297cbb504
1662280100 ML linezolid 2 MG/ML Injection [Zyvox]SBDce57225b-4580-442b-8c48-8045297cbb504
1662278100 ML linezolid 2 MG/ML InjectionSCDce57225b-4580-442b-8c48-8045297cbb504
1662280100 ML Zyvox 2 MG/ML InjectionSYce57225b-4580-442b-8c48-8045297cbb504
1662278linezolid 200 MG per 100 ML InjectionSYce57225b-4580-442b-8c48-8045297cbb504
1662280Zyvox 200 MG per 100 ML InjectionSYce57225b-4580-442b-8c48-8045297cbb504

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66298-5137-166298513701100 mL in 1 BAG (66298-5137-1) 100 ml2018-06-040000-00-00NoNoCurrent