FDA.reportPublic FDA data

NDC 0338-9636-01 - Zosyn

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
0338-9636
Requested NDC
0338-9636-01
Package NDCs from labels
0338-9636-01, 0338-9636-24
Manufacturer
Baxter Healthcare Corporation
Effective date
2026-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zosyn - Baxter Healthcare CorporationBaxter Healthcare Corporation2026-05-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0338-9636-242024-01-30C16284748780-11030e365-284f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN. ZOSYN ® (piperacillin and tazobactam) injection, for intravenous use Initial U.S. Approval: 1993
0338-9636-242024-01-30C16284748780-11030e365-284f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN. ZOSYN (piperacillin and tazobactam) injection, for intravenous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9636-01Zosyn50 mL in 1 BAGINJECTION, SOLUTION506
0338-9636-24Zosyn24 in 1 CARTONINJECTION, SOLUTION246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9636ZOSYN (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5Current NDC, 2 package rows20241211_8db6bd91-2106-4bfd-8cc8-38aaf1e18d17.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9636-01ML - Milliliter0338-96362cb2857f-9567-431d-9d83-a62294fc7fbc12023-05-05
0338-9636-24ML - Milliliter0338-9636598dbf5a-6f28-4dd5-bc5f-cb0e60c6c93a12023-05-05

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 19 of 28 · 559 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLCe53ebafc-3afa-4a1e-9313-fecd1c1c5d7c2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCba87ade3-4d41-40c0-9f6a-27e121a4136d2024-10-16Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLC2cfa6723-175b-4c4d-8212-266844b076102024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLCc78e0931-ec79-58e5-8658-7fe692dc3b8b2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.c18109cf-d5db-4cc1-83da-537c8ab0e05c2024-10-14Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMShandong Anxin Pharmaceutical Co., Ltd.f817b9be-b12b-48ac-8e4e-57ef6812eb322024-10-14Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: LX22YL083G
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: LX22YL083G
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMArmas Pharmaceuticals Inc.24d9b4f1-109c-4db4-8a99-03afff045b472024-09-27Warnings, Adverse reactionsExact identifier
rxcui: 1659137
unii: M98T69Q7HP
unii: UXA545ABTT
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMArmas Pharmaceuticals Inc.bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a2024-09-27Warnings, Adverse reactionsExact identifier
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
SODIUM BICARBONATESODIUM BICARBONATE INJECTION,Long Grove Pharmaceuticals, LLCa26d709b-b294-4b02-9a88-7e840f099a332024-09-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC3c5f0f65-8a54-4a55-ad4e-0f0be97631d72024-09-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLC80f4bdb8-131e-4485-b7a2-accd596d4cde2024-09-04Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin, TazobactamPIPERACILLIN SODIUM, TAZOBACTAM SODIUMSagent Pharmaceuticals83f4adcd-893c-4e9e-8f2b-e06299dcf34d2024-08-31Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMSandoz Incb1cb1314-d3e0-4b44-a1df-de14c32e8cc62024-08-23Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT

Reported adverse events (FAERS/openFDA)#

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