FDA.reportPublic FDA data

NDC 0338-9632-01 - 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
0338-9632
Requested NDC
0338-9632-01
Package NDCs from labels
0338-9632-01, 0338-9632-24
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
0338-9632-242024-01-30C16284748780-11030e365-284f-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
0338-9632-242024-01-30C16284748780-11030e365-284f-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
0338-9632-01Zosyn50 mL in 1 BAGINJECTION, SOLUTION506
0338-9632-24Zosyn24 in 1 CARTONINJECTION, SOLUTION246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9632ZOSYN (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
0338-9632-01ML - Milliliter0338-9632ca93780b-b5d8-4a16-99c2-9deb9652eea612023-05-05
0338-9632-24ML - Milliliter0338-96325b08da5a-ee9a-4754-928a-b2decf362dd212023-05-05

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 25 of 28 · 559 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEMedical Purchasing Solutions, LLCada63d44-3b37-b65d-e053-2a95a90aa0882023-05-03Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCd1636b56-ad83-4439-e053-2a95a90a135e2023-05-02Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Zosyn in Galaxy ContainersTAZOBACTAM SODIUM AND PIPERACILLIN SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6232023-03-15Warnings, Adverse reactionsExact identifier
application number: NDA050750
rxcui: 1659134
rxcui: 1659137
rxcui: 1659151
rxcui: 1659131
rxcui: 1659149
rxcui: 1659139
unii: M98T69Q7HP
unii: UXA545ABTT
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Anticoagulant Citrate Dextrose AANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATECitra Labs LLC5bcd261e-ebba-4ecb-af22-e5aaeb04499b2023-02-14Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Dextrose MonohydrateDEXTROSE MONOHYDRATEInternational Medication Systems, Limitedfcc7ac79-cd70-4f03-a4de-f051f9ca1f7d2022-12-20Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
25% Dextrose Infant25% DEXTROSE INFANTHF Acquisition Co. LLC, DBA Health First73d04839-a2bb-65dd-e053-2991aa0a82ca2022-12-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Company9c80dfee-8923-4d1f-85b0-98bd68b942122022-12-07Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Corporation50603082-bce5-49eb-9737-e04239cfb6952022-12-07Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Omeprazole, Sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEGuardian Drug Companye5c6c2cf-fb3b-456a-a0a0-be396d6f83192022-11-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: LX22YL083G
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: LX22YL083G
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: LX22YL083G
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCdc8208ea-a632-4291-a90b-2eba9a33bb402022-10-27Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT

Reported adverse events (FAERS/openFDA)#

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