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 12 of 29 · 565 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEMeijer Distribution Incbb7c1c5d-b915-42f5-a5a2-5f61b088028d2025-09-05WarningsExact identifier
unii: 8MDF5V39QO
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC668a2730-e95a-4639-a506-ae95a6502ca12025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Sodium Bicarbonate 10 GR (650 MG)SODIUM BICARBONATEAdvanced Rx LLC634e8d52-6d04-42f9-98f6-2634473b5dfd2025-09-01WarningsExact identifier
unii: 8MDF5V39QO
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEProPharma Distribution3d71b046-3e0b-054a-e063-6294a90a563a2025-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dextrose and Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEBaxter Healthcare Companydcbf1907-1841-4afc-ab5d-a9893a2d72562025-08-26Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 8MDF5V39QO
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLC39e19789-de4b-4fd1-ab1c-92f59496f4962025-08-19Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepackccf8e08c-2efb-4a92-a4c2-042dba2eacfa2025-08-13Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHenry Schein, Inc.ea9ad1a6-84f2-44d8-bf93-fb8f3d3fce9c2025-08-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLCa5d8625e-e630-4076-bc55-46ebe861c6a52025-08-08Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Bath Bomb 2-pack (Lemon)ALLANTOINCarolina Cannabis Creations LLC08c7c313-cf36-fb46-e063-6294a90a73042025-08-06WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2bf501-fd81-6ffa-e063-6394a90afe422025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2cf6fd-72cb-fa53-e063-6394a90a674a2025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Companybfc4224a-2fc9-4137-b4c6-9d2d6d9484132025-07-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Anti-EmpachoSODIUM BICARBONATEMenper Distributors, Inc.43807221-58f0-434d-be2d-fa0f54b95db82025-07-22WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATEMenper Distributors Inc.6efb4da0-03ae-4df6-acd7-e8023d20d4b32025-07-22WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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