FDA.reportPublic FDA data

Zyvox

Product NDC
0009-7807
11-digit product format
000097807
Labeler code
0009
Product ID
0009-7807_a31d18ac-569a-411f-a80f-5e926a1684fe
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
2015-02-18
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
Rxcui1662285, 1662286

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
780e0a7c-a57b-4ddb-82c2-fdccbc11064aProduct name920170814
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0009-7807-01Zyvox300 mL in 1 BAGINJECTION, SOLUTION30023
0009-7807-02Zyvox10 in 1 BOXINJECTION, SOLUTION1023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-7807-01ML - Milliliter0009-7807c5ff3042-7e83-4b46-8339-eab229c6f8cc12015-06-09
0009-7807-02ML - Milliliter0009-7807df08c8f2-4916-4254-bc2f-673bec09e68312015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LINEZOLIDACTIVE INGREDIENTISQ9I6J12JZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]3
LINEZOLIDACTIVE MOIETYISQ9I6J12JZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-7807ZYVOX (LINEZOLID) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]20Current NDC, Legacy NDC, 2 package rows20240927_3e5e9975-6f36-42e4-ab46-0e75dda83592.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1662285linezolid 600 MG in 300 ML InjectionPSN3e5e9975-6f36-42e4-ab46-0e75dda8359223
1662286ZYVOX 600 MG in 300 ML InjectionPSN3e5e9975-6f36-42e4-ab46-0e75dda8359223
1662286300 ML linezolid 2 MG/ML Injection [Zyvox]SBD3e5e9975-6f36-42e4-ab46-0e75dda8359223
1662285300 ML linezolid 2 MG/ML InjectionSCD3e5e9975-6f36-42e4-ab46-0e75dda8359223
1662286300 ML Zyvox 2 MG/ML InjectionSY3e5e9975-6f36-42e4-ab46-0e75dda8359223
1662285linezolid 600 MG per 300 ML InjectionSY3e5e9975-6f36-42e4-ab46-0e75dda8359223
1662286Zyvox 600 MG per 300 ML InjectionSY3e5e9975-6f36-42e4-ab46-0e75dda8359223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-7807-0100009780701300 mL in 1 BAG300 mlHistorical
0009-7807-020000978070210 BAG in 1 BOX (0009-7807-02) / 300 mL in 1 BAG (0009-7807-01) 10 bag2015-02-180000-00-00NoNoCurrent