Linezolid

Product NDC
67046-1576
11-digit product format
670461576
Labeler code
67046
Product ID
67046-1576_3dff6e84-a494-5993-e063-6394a90aa8f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA204239
Marketing category
ANDA
Marketing start
2025-09-04
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
67046-1576-3Linezolid30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSN3dff6eec-8662-335f-e063-6294a90ab1591
311347linezolid 600 MG Oral TabletSCD3dff6eec-8662-335f-e063-6294a90ab1591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1576-36704615760330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1576-3) 2025-09-04NoNoCurrent