FDA.reportPublic FDA data

Linezolid

Product NDC
63323-713
11-digit product format
633230713
Labeler code
63323
Product ID
63323-713_d151d608-d9c5-4b78-b99b-f0cb53e6c439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA204764
Marketing category
ANDA
Marketing start
2015-06-22
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
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-713-03Linezolid300 mL in 1 BAGINJECTION, SOLUTION3006
63323-713-13Linezolid10 in 1 CASEINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-713-03ML - Milliliter63323-713ecbfb961-eff1-4c28-8407-03ec56a8689812021-07-15
63323-713-13ML - Milliliter63323-713710525f1-a1d2-43c7-8cce-d5ea04d7a72712016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-713LINEZOLID (LINEZOLID) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20240502_cc3e3ea4-50aa-49ee-a8bc-fb48bfc8e014.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662285linezolid 600 MG in 300 ML InjectionPSNcc3e3ea4-50aa-49ee-a8bc-fb48bfc8e0146
1662285300 ML linezolid 2 MG/ML InjectionSCDcc3e3ea4-50aa-49ee-a8bc-fb48bfc8e0146
1662285linezolid 600 MG per 300 ML InjectionSYcc3e3ea4-50aa-49ee-a8bc-fb48bfc8e0146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-713-0363323071303300 mL in 1 BAG300 mlHistorical
63323-713-136332307131310 BAG in 1 CASE (63323-713-13) / 300 mL in 1 BAG (63323-713-03) 10 bag2015-06-220000-00-00NoNoCurrent