FDA.reportPublic FDA data

Linezolid

Product NDC
59762-1308
11-digit product format
597621308
Labeler code
59762
Product ID
59762-1308_709b7bad-813b-4e62-935a-ecde7357d391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
SUSPENSION
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021132
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-05-18
Substance
LINEZOLID
Active strength
100 mg/5mL
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Linezolid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINEZOLID100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J
Rxcui311345

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
59762-1308-1Linezolid150 mL in 1 BOTTLESUSPENSION15015
59762-1308-4Linezolid150 mL in 1 BOTTLESUSPENSION15015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1308-1ML - Milliliter59762-13084ffae16c-ae3c-4383-8616-61ab8fd6f7e512016-01-13
59762-1308-4ML - Milliliter59762-1308c8a2f913-21ed-47bd-b6e8-610a9f0edea112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1308LINEZOLID SUSPENSION [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 2 package rows20250529_83a84897-ccca-42a1-ab1a-bbf1d43a982b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311345linezolid 100 MG in 5 mL Oral SuspensionPSN83a84897-ccca-42a1-ab1a-bbf1d43a982b15
311345linezolid 20 MG/ML Oral SuspensionSCD83a84897-ccca-42a1-ab1a-bbf1d43a982b15
311345linezolid 100 MG per 5 ML Oral SuspensionSY83a84897-ccca-42a1-ab1a-bbf1d43a982b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-1308-159762130801150 mL in 1 BOTTLE (59762-1308-1) 150 ml2015-05-180000-00-00NoNoCurrent
59762-1308-459762130804150 mL in 1 BOTTLE (59762-1308-4) 150 ml2023-03-30NoNoHistorical