FDA.reportPublic FDA data

Zyvox

Product NDC
0009-5140
11-digit product format
000095140
Labeler code
0009
Product ID
0009-5140_f61349cd-d7b8-4400-b433-01abcdb0cc99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA021131
Marketing category
NDA
Marketing start
2000-04-18
Substance
LINEZOLID
Active strength
600 mg/300mL
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
Zyvox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINEZOLID600 mg/300mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiISQ9I6J12J

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
0009-5140-01Zyvox300 mL in 1 BAGINJECTION, SOLUTION30069
0009-5140-04Zyvox10 in 1 BOXINJECTION, SOLUTION1069

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-5140-01ML - Milliliter0009-51405c3877a8-e0b0-4bea-aa04-e3ccffa1c48b12012-07-24
0009-5140-04ML - Milliliter0009-51404b3b2471-2321-441e-9340-24e9fe2477fe12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LINEZOLIDACTIVE INGREDIENTISQ9I6J12JZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
LINEZOLIDACTIVE MOIETYISQ9I6J12JZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
MANNITOLINACTIVE INGREDIENT3OWL53L36AZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
SUCROSEINACTIVE INGREDIENTC151H8M554ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-5140ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) GRANULE, FOR SUSPENSION ZYVOX (LINEZOLID) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]64Current NDC, Legacy NDC, 2 package rows20240726_6e70e63b-bfd5-478d-a8ee-8ba22c9efabd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311345linezolid 100 MG in 5 mL Oral SuspensionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662278linezolid 200 MG in 100 ML InjectionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662285linezolid 600 MG in 300 ML InjectionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
311347linezolid 600 MG Oral TabletPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
581614ZYVOX 100 MG in 5 mL Oral SuspensionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662280ZYVOX 200 MG in 100 ML InjectionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662286ZYVOX 600 MG in 300 ML InjectionPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
262091Zyvox 600 MG Oral TabletPSN6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662280100 ML linezolid 2 MG/ML Injection [Zyvox]SBD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662286300 ML linezolid 2 MG/ML Injection [Zyvox]SBD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
581614linezolid 20 MG/ML Oral Suspension [Zyvox]SBD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
262091linezolid 600 MG Oral Tablet [Zyvox]SBD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662278100 ML linezolid 2 MG/ML InjectionSCD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662285300 ML linezolid 2 MG/ML InjectionSCD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
311345linezolid 20 MG/ML Oral SuspensionSCD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
311347linezolid 600 MG Oral TabletSCD6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662280100 ML Zyvox 2 MG/ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662286300 ML Zyvox 2 MG/ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
311345linezolid 100 MG per 5 ML Oral SuspensionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662278linezolid 200 MG per 100 ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662285linezolid 600 MG per 300 ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
581614Zyvox 100 MG per 5 ML Oral SuspensionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
581614Zyvox 20 MG/ML Oral SuspensionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662280Zyvox 200 MG per 100 ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
262091Zyvox 600 MG Oral TabletSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69
1662286Zyvox 600 MG per 300 ML InjectionSY6e70e63b-bfd5-478d-a8ee-8ba22c9efabd69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-5140-0100009514001300 mL in 1 BAG300 mlHistorical
0009-5140-040000951400410 BAG in 1 BOX (0009-5140-04) / 300 mL in 1 BAG (0009-5140-01) 10 bag2000-04-180000-00-00NoNoCurrent