FDA.reportPublic FDA data

Linezolid

Product NDC
0409-4883
11-digit product format
004094883
Labeler code
0409
Product ID
0409-4883_6cd59961-fd78-4d62-bf0d-a42a02f10e48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LINEZOLID
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA206473
Marketing category
NDA
Marketing start
2015-06-18
Substance
LINEZOLID
Active strength
2 mg/mL
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Linezolid
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4883-01Linezolid1 in 1 POUCHINJECTION, SOLUTION120
0409-4883-01Linezolid10 in 1 CASEINJECTION, SOLUTION1020
0409-4883-03Linezolid300 mL in 1 BAGINJECTION, SOLUTION30020
0409-4883-10Linezolid10 in 1 CASEINJECTION, SOLUTION1020
0409-4883-10Linezolid1 in 1 POUCHINJECTION, SOLUTION120
0409-4883-11Linezolid300 mL in 1 BAGINJECTION, SOLUTION30020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4883-01ML - Milliliter0409-4883950fb9a1-2a9a-484b-a68d-eb0f335ce70a12015-07-20
0409-4883-03ML - Milliliter0409-4883f18c2e38-3b0f-455b-a255-2ba9e35b28a512023-07-06
0409-4883-10ML - Milliliter0409-48835412bfdc-08bd-455f-8a08-5f01a02cf1cd12023-07-06
0409-4883-11ML - Milliliter0409-488310a830b7-4c1d-4a69-9a37-81a3ab78b18112019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LINEZOLIDACTIVE INGREDIENTISQ9I6J12JLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
LINEZOLIDACTIVE MOIETYISQ9I6J12JLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4883LINEZOLID INJECTION, SOLUTION [HOSPIRA, INC.]18Current NDC, Legacy NDC, 6 package rows20250508_c401f1a8-cc37-461b-bfef-f2e156629bf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662285linezolid 600 MG in 300 ML InjectionPSNc401f1a8-cc37-461b-bfef-f2e156629bf820
1662285300 ML linezolid 2 MG/ML InjectionSCDc401f1a8-cc37-461b-bfef-f2e156629bf820
1662285linezolid 600 MG per 300 ML InjectionSYc401f1a8-cc37-461b-bfef-f2e156629bf820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4883-010040948830110 POUCH in 1 CASE (0409-4883-01) > 1 BAG in 1 POUCH > 300 mL in 1 BAG (0409-4883-11) 10 pouch2015-06-180000-00-00NoNoCurrent
0409-4883-0300409488303300 mL in 1 BAG300 mlHistorical
0409-4883-100040948831010 POUCH in 1 CASE (0409-4883-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-03) 10 pouch2023-06-19NoNoCurrent
0409-4883-1100409488311300 mL in 1 BAG300 mlHistorical