FDA.reportPublic FDA data

Linezolid

Product NDC
66794-219
11-digit product format
667940219
Labeler code
66794
Product ID
66794-219_3f9d8cdd-0149-bcf4-e063-6394a90a01ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Linezolid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Piramal Critical Care Inc
Application
ANDA207001
Marketing category
ANDA
Marketing start
2024-03-08
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
Rxcui1662285

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
66794-219-43Linezolid10 in 1 CARTONINJECTION, SOLUTION109
66794-219-63Linezolid300 mL in 1 BAGINJECTION, SOLUTION3009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-219-43ML - Milliliter66794-2190491f904-490a-436b-bc1e-32b701eb64f712020-02-13
66794-219-63ML - Milliliter66794-21971130b99-e12f-4ed1-ab02-6d06dd553bc612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-219LINEZOLID INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]8Current NDC, Legacy NDC, 2 package rows20241025_95b8fd63-d018-8062-e053-2995a90ab96d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662285linezolid 600 MG in 300 ML InjectionPSN95b8fd63-d018-8062-e053-2995a90ab96d9
1662285300 ML linezolid 2 MG/ML InjectionSCD95b8fd63-d018-8062-e053-2995a90ab96d9
1662285linezolid 600 MG per 300 ML InjectionSY95b8fd63-d018-8062-e053-2995a90ab96d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-219-436679402194310 BAG in 1 CARTON (66794-219-43) / 300 mL in 1 BAG (66794-219-63) 10 bag2024-03-080000-00-00NoNoCurrent
66794-219-6366794021963300 mL in 1 BAG300 mlHistorical