Linezolid

Product NDC
60687-754
11-digit product format
606870754
Labeler code
60687
Product ID
60687-754_03380d95-6c5f-1701-e063-6294a90abb95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA211813
Marketing category
ANDA
Marketing start
2023-08-20
Substance
LINEZOLID
Active strength
100 mg/5mL
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
LINEZOLID100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J
Rxcui311345

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
60687-754-05Linezolid150 mL in 1 BOTTLE, GLASSGRANULE, FOR SUSPENSION1501
60687-754-05Linezolid1 in 1 CARTONGRANULE, FOR SUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-754LINEZOLID GRANULE, FOR SUSPENSION [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20230820_e9ac1ad7-7a23-463d-a467-f0ecc7e523e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311345linezolid 100 MG in 5 mL Oral SuspensionPSNe9ac1ad7-7a23-463d-a467-f0ecc7e523e71
311345linezolid 20 MG/ML Oral SuspensionSCDe9ac1ad7-7a23-463d-a467-f0ecc7e523e71
311345linezolid 100 MG per 5 ML Oral SuspensionSYe9ac1ad7-7a23-463d-a467-f0ecc7e523e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60687-754-05606870754051 BOTTLE, GLASS in 1 CARTON (60687-754-05) / 150 mL in 1 BOTTLE, GLASS2023-08-20NoNoCurrent