FDA.reportPublic FDA data

Linezolid

Product NDC
60687-309
11-digit product format
606870309
Labeler code
60687
Product ID
60687-309_278685f1-7b24-ea7e-e063-6394a90a9713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA204239
Marketing category
ANDA
Marketing start
2018-02-15
Substance
LINEZOLID
Active strength
600 mg/1
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
Linezolid
Listing expiration
2026-12-31

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
60687-309-11Linezolid1 in 1 BLISTER PACKTABLET, FILM COATED16
60687-309-21Linezolid30 in 1 BOX, UNIT-DOSETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-309-11EA - Each60687-309daa3e0c3-07a1-4675-b388-2ecd9867e6ec12018-03-08
60687-309-21EA - Each60687-309bf83483c-1b15-4836-99ff-0b45d9955f3512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-309LINEZOLID TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20241124_bc12bd87-5ef0-4ebe-bc00-cbd7896ce08c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSNbc12bd87-5ef0-4ebe-bc00-cbd7896ce08c6
311347linezolid 600 MG Oral TabletSCDbc12bd87-5ef0-4ebe-bc00-cbd7896ce08c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-309-11606870309111 in 1 BLISTER PACKHistorical
60687-309-216068703092130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-309-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-309-11) 30 blister pack2018-02-150000-00-00NoNoCurrent