FDA.reportPublic FDA data

NDC 68547-211 - Xacduro

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68547-211
Package NDCs from labels
68547-211-20
Manufacturer
La Jolla Pharmaceutical Company | Entasis Therapeutics Inc. (ETI)
Effective date
2025-11-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Xacduro - La Jolla Pharmaceutical Company | Entasis Therapeutics Inc. (ETI)La Jolla Pharmaceutical Company | Entasis Therapeutics Inc. (ETI)2025-11-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68547-211XACDURO (SULBACTAM AND DURLOBACTAM) KIT [LA JOLLA PHARMACEUTICAL COMPANY]8Unmatched20250331_c0167aec-a89d-4e96-afe5-2ccf3e89fe72.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLCadc92303-b62b-41c8-becf-9c3a4e8c3a6b2025-08-12Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC2709e9fc-2341-4382-af72-c2e3201bd77a2025-08-12Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMArmas Pharmaceuticals Inc.ac6f8158-9d7e-4b99-af3c-0407c5287b572025-07-31Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.9f2ff165-2a21-4155-a4f0-57885a83c7dc2025-07-24Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMAvenacy, LLC577dd6f0-d56a-4c82-9f72-274c3a4a0f012025-04-25Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMAvenacy, LLC4446d4c8-056d-4bc3-8f58-21255b0633982025-04-25Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticals35606b43-5914-423c-9bc7-fa3957eb25632024-11-18Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMNorthStar Rx, LLC5e8d35cb-e93d-42ad-a02c-0dbf04910f612024-08-13Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMNorthStar Rx, LLC1e5004f1-e79e-4e0b-9f3f-25f6bbc152552024-06-27Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.