FDA.reportPublic FDA data

Zyvox

Product NDC
0009-5138
11-digit product format
000095138
Labeler code
0009
Product ID
0009-5138_f61349cd-d7b8-4400-b433-01abcdb0cc99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linezolid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA021130
Marketing category
NDA
Marketing start
2015-10-12
Marketing end
2027-02-28
Substance
LINEZOLID
Active strength
600 mg/1
Pharmacologic classes
Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zyvox

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINEZOLID600 mg/1

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
0009-5138-02Zyvox20 in 1 BOTTLETABLET, FILM COATED2069
0009-5138-03Zyvox1 in 1 BLISTER PACKTABLET, FILM COATED169
0009-5138-03Zyvox30 in 1 BOX, UNIT-DOSETABLET, FILM COATED3069

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-5138-02EA - Each0009-5138f09c0876-2963-4272-8451-ef1412e460ce12015-11-12
0009-5138-03EA - Each0009-513867d47854-74d4-4a88-a137-fc4efbf5033312015-11-12

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
0009-5138ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) GRANULE, FOR SUSPENSION ZYVOX (LINEZOLID) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]64Current NDC, Legacy NDC, 3 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
0009-5138-020000951380220 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02) 2015-10-122027-02-28NoNoCurrent
0009-5138-030000951380330 BLISTER PACK in 1 BOX, UNIT-DOSE (0009-5138-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2015-10-120000-00-00NoNoCurrent