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 28 of 28 · 559 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: LX22YL083G
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.2557199a-5f60-49d8-b093-1e07002112432019-11-18Exact identifier
unii: LX22YL083G
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.794f724c-87f0-49c1-9b26-c9e4919783132019-11-18Exact identifier
unii: LX22YL083G
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.5c7d3287-883a-459b-9214-074a583c8a592019-11-18Exact identifier
unii: LX22YL083G
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.448a1dc5-7a98-4b2f-82af-4b92de05cfc32019-11-18Exact identifier
unii: LX22YL083G
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation0332f34a-7038-47cc-ba59-d55cad6b73ca2019-08-05Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride in DextrosePOTASSIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Company45de5402-5e61-4bbd-8bbc-5e3392c9920e2019-07-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride in Dextrose and Sodium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBaxter Healthcare Companyc553fed1-3de5-4826-8eff-633b5923bf0b2019-02-21Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
SODIUM BICARBONATESODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLC15605a6d-6c90-47d5-9d1f-f66a3f27d5fc2017-12-13WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATERichmond Pharmaceuticals, Inc.e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce2017-11-01WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATERichmond Pharmaceuticals, Inc.fa10d93d-b3ed-4675-a117-f573d9e72bca2017-10-30WarningsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCe9698a4f-1a95-4f28-a945-e8009d1d6dd42017-09-27Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.051f7347-5a76-4664-8fe2-e61b3dfcb0e42014-08-27Exact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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