FDA.reportPublic FDA data

Linezolid

Product NDC
85766-075
11-digit product format
857660075
Labeler code
85766
Product ID
85766-075_50317545-8e72-a9c1-e063-6394a90a1c8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA078845
Marketing category
ANDA
Marketing start
2023-11-20
Substance
LINEZOLID
Active strength
600 mg/1
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
LINEZOLID600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J
Rxcui311347

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
85766-075-20Linezolid20 in 1 BOTTLETABLET202
85766-075-30Linezolid30 in 1 BOTTLETABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSN561abed1-c0f9-40ee-98a8-7c710bcde8222
311347linezolid 600 MG Oral TabletSCD561abed1-c0f9-40ee-98a8-7c710bcde8222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-075-208576600752020 TABLET in 1 BOTTLE (85766-075-20) 20 tablet2025-10-10NoNoCurrent
85766-075-308576600753030 TABLET in 1 BOTTLE (85766-075-30) 30 tablet2025-10-10NoNoCurrent