Linezolid

Product NDC
66298-7131
11-digit product format
662987131
Labeler code
66298
Product ID
66298-7131_1d77a459-7013-fb55-e063-6294a90a0dc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LINEZOLID
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hp Halden Pharma AS
Application
ANDA204764
Marketing category
ANDA
Marketing start
2017-07-27
Substance
LINEZOLID
Active strength
2 mg/mL
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
LINEZOLID2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J
Rxcui1662285

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66298-7131-3Linezolid300 mL in 1 BAGINJECTION, SOLUTION3003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66298-7131LINEZOLID INJECTION, SOLUTION [HP HALDEN PHARMA AS]3Current NDC, Legacy NDC, 1 package rows20240719_217f3ee2-2534-4c32-8e9d-09b6d65df4af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662285linezolid 600 MG in 300 ML InjectionPSN217f3ee2-2534-4c32-8e9d-09b6d65df4af3
1662285300 ML linezolid 2 MG/ML InjectionSCD217f3ee2-2534-4c32-8e9d-09b6d65df4af3
1662285linezolid 600 MG per 300 ML InjectionSY217f3ee2-2534-4c32-8e9d-09b6d65df4af3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66298-7131-366298713103300 mL in 1 BAG (66298-7131-3) 300 ml2017-07-270000-00-00NoNoCurrent