FDA.reportPublic FDA data

AVYCAZ

Product NDC
0456-2700
11-digit product format
004562700
Labeler code
0456
Product ID
0456-2700_5da940bc-28c3-4e0c-ac51-912f8cc1beb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ceftazidime, avibactam
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Allergan, Inc.
Application
NDA206494
Marketing category
NDA
Marketing start
2014-12-26
Substance
AVIBACTAM SODIUM; CEFTAZIDIME
Active strength
.5; 2 g/1; g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AVYCAZ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVIBACTAM SODIUM.5 g/1
CEFTAZIDIME2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9V824P8TAI, 9M416Z9QNR
Rxcui1603840, 1603845

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
458b18b0-b105-44ac-b090-378873a4e07bProduct name120251118
fb7d24f2-fcd1-4dc6-b9d0-b1f65bfffab5Product name120150409

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-2700-01AVYCAZ1 in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION124
0456-2700-10AVYCAZ10 in 1 CARTONPOWDER, FOR SOLUTION1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-2700-01EA - Each0456-2700c85cb800-91d5-4c33-9abb-edcf5f2e8b1c12015-04-03
0456-2700-10EA - Each0456-270047fd7ba9-7b21-4b37-a612-a71e43daea0d12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
avibactam sodiumACTIVE INGREDIENT9V824P8TAIAVYCAZ (CEFTAZIDIME, AVIBACTAM) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC.]2
ceftazidimeACTIVE INGREDIENT9M416Z9QNRAVYCAZ (CEFTAZIDIME, AVIBACTAM) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC.]2
avibactamACTIVE MOIETY7352665165AVYCAZ (CEFTAZIDIME, AVIBACTAM) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC.]2
ceftazidime anhydrousACTIVE MOIETYDZR1ENT301AVYCAZ (CEFTAZIDIME, AVIBACTAM) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC.]2
sodium carbonateINACTIVE INGREDIENT45P3261C7TAVYCAZ (CEFTAZIDIME, AVIBACTAM) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-2700AVYCAZ (CEFTAZIDIME, AVIBACTAM) POWDER, FOR SOLUTION [ALLERGAN, INC.]24Current NDC, Legacy NDC, 2 package rows20250504_d9c2803f-dc9c-4b19-b4a3-8303bc8c15fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1603845Avycaz 2.5 GM InjectionPSNd9c2803f-dc9c-4b19-b4a3-8303bc8c15fd24
1603840cefTAZidime / avibactam 2.5 GM InjectionPSNd9c2803f-dc9c-4b19-b4a3-8303bc8c15fd24
1603845avibactam 500 MG / ceftazidime 2000 MG Injection [Avycaz]SBDd9c2803f-dc9c-4b19-b4a3-8303bc8c15fd24
1603840avibactam 500 MG / ceftazidime 2000 MG InjectionSCDd9c2803f-dc9c-4b19-b4a3-8303bc8c15fd24
1603845Avycaz (ceftazidime / avibactam) 2.5 GM InjectionSYd9c2803f-dc9c-4b19-b4a3-8303bc8c15fd24
1603840ceftazidime / avibactam 2.5 GM InjectionSYd9c2803f-dc9c-4b19-b4a3-8303bc8c15fd24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0456-2700-01004562700011 in 1 VIAL, SINGLE-DOSEHistorical
0456-2700-100045627001010 VIAL, SINGLE-DOSE in 1 CARTON (0456-2700-10) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0456-2700-01) 2014-12-260000-00-00NoNoCurrent