Xacduro

Product NDC
68547-111
11-digit product format
685470111
Labeler code
68547
Product ID
68547-111_2606ce2c-ad3a-4c58-be0d-9a696d366d64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulbactam and durlobactam
Dosage form
KIT
Labeler
La Jolla Pharmaceutical Company
Application
NDA216974
Marketing category
NDA
Marketing start
2023-06-06
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2665012, 2665017

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1f6437d4-fe6e-4912-889c-84576c1da4d8Product name120231019
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68547-111-10Xacduro1 in 1 CARTONKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68547-111-10EA - Each68547-11101dca927-855b-4029-bd7b-d76cfd0cda2312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68547-111XACDURO (SULBACTAM AND DURLOBACTAM) KIT [LA JOLLA PHARMACEUTICAL COMPANY]8Current NDC, 1 package rows20250331_c0167aec-a89d-4e96-afe5-2ccf3e89fe72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2665012durlobactam 1 GM / sulbactam 1 GM Injection KitPSNc0167aec-a89d-4e96-afe5-2ccf3e89fe7211
2665017XACDURO 1 GM / 1 GM Injection KitPSNc0167aec-a89d-4e96-afe5-2ccf3e89fe7211
2665017durlobactam 1000 MG / sulbactam 1000 MG Injection [Xacduro]SBDc0167aec-a89d-4e96-afe5-2ccf3e89fe7211
2665012durlobactam 1000 MG / sulbactam 1000 MG InjectionSCDc0167aec-a89d-4e96-afe5-2ccf3e89fe7211
2665012durlobactam 1 GM / sulbactam 1 GM Injection KitSYc0167aec-a89d-4e96-afe5-2ccf3e89fe7211
2665017Xacduro 1 GM / 1 GM Injection KitSYc0167aec-a89d-4e96-afe5-2ccf3e89fe7211
2665017Xacduro 1000 MG / 1000 MG Injection KitSYc0167aec-a89d-4e96-afe5-2ccf3e89fe7211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68547-111-10685470111101 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30) 1 kit2023-06-06NoNoCurrent