FDA.reportPublic FDA data

Linezolid

Product NDC
57664-683
11-digit product format
576640683
Labeler code
57664
Product ID
57664-683_2e599906-ac35-54ab-e063-6394a90ac605
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA207354
Marketing category
ANDA
Marketing start
2017-02-01
Substance
LINEZOLID
Active strength
600 mg/300mL
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/300mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J
Rxcui1662278, 1662285

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
51fd7f50-f4ab-45ea-852e-f4101dca346bProduct name120150622
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-683-31Linezolid300 mL in 1 BAGINJECTION, SOLUTION30019
57664-683-57Linezolid10 in 1 BOXINJECTION, SOLUTION1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-683-31ML - Milliliter57664-683cca028ae-e970-41bc-b307-e39aa792431412017-09-11
57664-683-57ML - Milliliter57664-6830b5a2567-f9b7-4cde-a5e8-fef439ffbf2a12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-683LINEZOLID INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]19Current NDC, Legacy NDC, 2 package rows20250221_870c9600-04d5-4b44-a5b5-02252a310f22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662278linezolid 200 MG in 100 ML InjectionPSN870c9600-04d5-4b44-a5b5-02252a310f2219
1662285linezolid 600 MG in 300 ML InjectionPSN870c9600-04d5-4b44-a5b5-02252a310f2219
1662278100 ML linezolid 2 MG/ML InjectionSCD870c9600-04d5-4b44-a5b5-02252a310f2219
1662285300 ML linezolid 2 MG/ML InjectionSCD870c9600-04d5-4b44-a5b5-02252a310f2219
1662278linezolid 200 MG per 100 ML InjectionSY870c9600-04d5-4b44-a5b5-02252a310f2219
1662285linezolid 600 MG per 300 ML InjectionSY870c9600-04d5-4b44-a5b5-02252a310f2219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-683-3157664068331300 mL in 1 BAG300 mlHistorical
57664-683-575766406835710 BAG in 1 BOX (57664-683-57) / 300 mL in 1 BAG (57664-683-31) 10 bag2017-02-010000-00-00NoNoCurrent