linezolid

Product NDC
62135-442
11-digit product format
621350442
Labeler code
62135
Product ID
62135-442_42c9dc2a-45a8-d122-e063-6294a90ac4c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA210702
Marketing category
ANDA
Marketing start
2019-04-25
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
62135-442-20linezolid20 in 1 BOTTLETABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-442LINEZOLID TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241030_9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311347linezolid 600 MG Oral TabletPSN9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cf3
311347linezolid 600 MG Oral TabletSCD9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-442-206213504422020 TABLET in 1 BOTTLE (62135-442-20) 20 tablet2023-02-21NoNoCurrent