FDA.reportPublic FDA data

NDC 68547-211-20 - 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
Requested NDC
68547-211-20
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 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.139b4b2e-46f7-44a8-9cc1-774afa463b802026-07-23Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2026-07-22Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticalsa67ae347-487d-4751-a841-b321e81db26f2026-07-21Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig155c7ec0-5862-404f-b1d0-f278f8a8bbda2026-07-10Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig12eeb72a-403d-41be-bae4-4cb9308628842026-07-09Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC72a37674-8cb2-4b40-aac8-d345ffcf22f22026-06-23Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC9a722de6-9dc0-4fb9-b63a-225385aa33142026-06-23Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC77158167-0c1e-4f01-a5b0-a3df8ad121f52026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc42026-06-10Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMedical Purchasing Solutions, LLC.4e81c215-2ab6-87c6-e063-6294a90ac28c2026-04-02Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.a65a70bf-4283-4bc0-b576-00c9ab29bd642026-03-25Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.d3026cc0-95d8-44cf-be47-b5ebb8fd45682026-03-25Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMHospira, Incdc374fa4-350b-425d-a7db-7099fdc64cf12026-01-21Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC437a26f4-776b-4f74-99b2-09ad79831b0c2025-12-18Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMONESOURCE SPECIALTY PHARMA LIMITED573aca0c-111e-4ed3-9bcd-18136cae12cc2025-11-28Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
2606ce2c-ad3a-4c58-be0d-9a696d366d64c0167aec-a89d-4e96-afe5-2ccf3e89fe722025-11-26Warnings, Adverse reactionsExact identifier
spl id: 2606ce2c-ad3a-4c58-be0d-9a696d366d64
spl set id: c0167aec-a89d-4e96-afe5-2ccf3e89fe72
ampicillin sodium and sulbactam sodiumAMPICILLIN SODIUM AND SULBACTAM SODIUMONESOURCE SPECIALTY PHARMA LIMITED44181723-ef09-301b-e063-6394a90a2cad2025-11-21Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC16fdfdb9-9e26-48d0-8838-570d30c8e8972025-11-04Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMArmas Pharmaceuticals Inc.409f8a6d-f54f-415f-994c-ecd2b820caab2025-10-31Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6
ampicillin sodium and sulbactam sodiumAMPICILLIN SODIUM AND SULBACTAM SODIUMCivica, Inc.e98a36a1-b75b-42b9-ad1a-05004e9587b62025-09-08Warnings, Adverse reactionsExact identifier
unii: DKQ4T82YE6

Reported adverse events (FAERS/openFDA)#

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