Linezolid

Product NDC
59762-1307
11-digit product format
597621307
Labeler code
59762
Product ID
59762-1307_c553c285-1954-4f89-8988-3bada9c4a65e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021130
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-10-12
Marketing end
2026-08-31
Substance
LINEZOLID
Active strength
600 mg/1
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Linezolid

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
59762-1307-1Linezolid20 in 1 BOTTLETABLET, FILM COATED2016
59762-1307-2Linezolid1 in 1 BLISTER PACKTABLET, FILM COATED116
59762-1307-2Linezolid20 in 1 BOX, UNIT-DOSETABLET, FILM COATED2016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1307-1EA - Each59762-1307fa06653c-ce85-4862-9d85-2b33832cca5212016-01-13
59762-1307-2EA - Each59762-1307de480bc2-6551-415e-b38c-e300d16e9b4f12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1307LINEZOLID TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 3 package rows20250529_374af2a7-d994-40bd-a86a-cd9038d0b72c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSN374af2a7-d994-40bd-a86a-cd9038d0b72c16
311347linezolid 600 MG Oral TabletSCD374af2a7-d994-40bd-a86a-cd9038d0b72c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-1307-15976213070120 TABLET, FILM COATED in 1 BOTTLE (59762-1307-1) 2015-10-120000-00-00NoNoCurrent
59762-1307-25976213070220 BLISTER PACK in 1 BOX, UNIT-DOSE (59762-1307-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK20 blister pack2015-10-122026-08-31NoNoCurrent