FDA.reportPublic FDA data

ZERBAXA

Product NDC
67919-030
11-digit product format
679190030
Labeler code
67919
Product ID
67919-030_23d9b7be-abf3-4ca6-bce8-d80643a708e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ceftolozane and tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
NDA206829
Marketing category
NDA
Marketing start
2014-12-19
Substance
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
Active strength
1; .5 g/10mL; g/10mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTOLOZANE SULFATE1 g/10mL
TAZOBACTAM SODIUM.5 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7R247U84HY, UXA545ABTT
Rxcui1597615, 1597620

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5fa255cf-091e-4504-8ebf-eef4259776e8Product name120260112
a6bfe911-d09e-4049-bcde-a3213184a72cProduct name820240501
61877847-a958-4874-a7cf-2bbeff51a37bProduct name220180717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
e0d9b1cf-1fe5-42a8-b30f-70b3a7bd8d22Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67919-030-012020-07-22C16284748780-1ab0e2407-2d9f-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ZERBAXA safely and effectively. See full prescribing information for ZERBAXA. ZERBAXA ® (ceftolozane and tazobactam) for injection, for intravenous use Initial U.S. Approval: 2014
67919-030-012020-07-22C16284748780-1ab0e2407-2d9f-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ZERBAXA safely and effectively. See full prescribing information for ZERBAXA. ZERBAXA ® (ceftolozane and tazobactam) for injection, for intravenous use Initial U.S. Approval: 2014
67919-030-012020-07-22C16284748780-1ab0e2407-2d9f-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ZERBAXA safely and effectively. See full prescribing information for ZERBAXA. ZERBAXA ® (ceftolozane and tazobactam) for injection, for intravenous use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67919-030-01ZERBAXA10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1023
67919-030-01ZERBAXA10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67919-030-01EA - Each67919-0309c8d4f34-1f06-49b8-8c78-f9eee68aad7212015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ceftolozane sulfateACTIVE INGREDIENT7R247U84HYZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]4
tazobactam sodiumACTIVE INGREDIENTUXA545ABTTZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]4
ceftolozaneACTIVE MOIETY37A4IES95QZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]4
tazobactamACTIVE MOIETYSE10G96M8WZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]4
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]4
ArginineINACTIVE INGREDIENT94ZLA3W45FZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]4
sodium chlorideINACTIVE INGREDIENT451W47IQ8XZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67919-030ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]20Current NDC, Legacy NDC, 2 package rows20241114_70ac1d90-eff3-4f0b-9f46-5846c571b32f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597615ceftolozane / tazobactam 1.5 GM InjectionPSN70ac1d90-eff3-4f0b-9f46-5846c571b32f23
1597620Zerbaxa 1.5 GM InjectionPSN70ac1d90-eff3-4f0b-9f46-5846c571b32f23
1597620ceftolozane 1000 MG / tazobactam 500 MG Injection [Zerbaxa]SBD70ac1d90-eff3-4f0b-9f46-5846c571b32f23
1597615ceftolozane 1000 MG / tazobactam 500 MG InjectionSCD70ac1d90-eff3-4f0b-9f46-5846c571b32f23
1597615ceftolozane (as ceftolozane sulfate) 1 GM / tazobactam (as tazobactam sodium) 500 MG InjectionSY70ac1d90-eff3-4f0b-9f46-5846c571b32f23
1597615ceftolozane 1 GM / tazobactam 0.5 GM InjectionSY70ac1d90-eff3-4f0b-9f46-5846c571b32f23
1597620Zerbaxa 1.5 GM InjectionSY70ac1d90-eff3-4f0b-9f46-5846c571b32f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67919-030-016791900300110 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) / 10 mL in 1 VIAL, SINGLE-DOSE2014-12-190000-00-00NoNoCurrent