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 20 of 28 · 559 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMHospira, Inc5e8bbfcd-3618-43ed-a158-9d524426fdc52024-08-23Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
DextroseDEXTROSE MONOHYDRATEFRESENIUS KABI USA, LLC576a22d8-5f2f-497e-80ad-1842ca74bb532024-08-22Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
unii: 8MDF5V39QO
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: 8MDF5V39QO
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Omeprazole/Sodiium BicarbonateOMEPRAZOLE/SODIIUM BICARBONATEDirect_rx1f7f63c1-17c2-9a05-e063-6394a90abc6f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsExact identifier
unii: 8MDF5V39QO
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
unii: 8MDF5V39QO
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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