NDC 65219-259-05 - Piperacillin and Tazobactam

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
65219-259
Requested NDC
65219-259-05
Package NDCs from labels
65219-259-05, 65219-259-45, 65219-259-15, 65219-259-55
Manufacturer
Fresenius Kabi USA, LLC | Mitim S.r.I.
Effective date
2026-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Piperacillin and Tazobactam - Fresenius Kabi USA, LLC | Mitim S.r.I.Fresenius Kabi USA, LLC | Mitim S.r.I.2026-09-02HUMAN PRESCRIPTION DRUG LABEL
Piperacillin and Tazobactam - Fresenius Kabi USA, LLC | Mitim S.r.I.Fresenius Kabi USA, LLC | Mitim S.r.I.2021-05-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-259-05Piperacillin and Tazobactam20 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,204
65219-259-45Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104
65219-259-15Piperacillin and Tazobactam20 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,201
65219-259-55Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-259PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20250516_a798faf5-cd97-4e35-a700-94c372978c46.zip
65219-259PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]1Current NDC, Legacy NDC, 2 package rows20210524_b9bd733c-1176-42cb-b318-1223b7e48dcb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-259-05EA - Each65219-25937246466-bb4b-41f6-abae-934ab88234d212021-09-07
65219-259-15EA - Each65219-259eef3f28e-e037-4d94-9e37-01849206d83c12021-09-07
65219-259-45EA - Each65219-259e7a9019c-2606-4b23-bb03-6915fad17a1e12021-09-07
65219-259-55EA - Each65219-259438b3b40-54f5-4b3f-9cef-b0b3fbefcf3d12021-09-07

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 1 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZosynPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMBaxter Healthcare Corporation8db6bd91-2106-4bfd-8cc8-38aaf1e18d172026-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
ZERBAXACEFTOLOZANE AND TAZOBACTAMMerck Sharp & Dohme LLC70ac1d90-eff3-4f0b-9f46-5846c571b32f2026-05-12Warnings, Adverse reactionsExact identifier
unii: UXA545ABTT
Piperacillin and Tazobactam and Sodium ChloridePIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDEB. Braun Medical Inc.a63ca653-27d4-45fe-a744-77e0efe452202026-05-08Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMCivica, Inc.19e89f8b-316b-4dd2-9724-bfe0faeba4082025-12-12Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLC2cd82553-79dc-45f0-9755-2c08df524ed52025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMCivica, Inc.7aebc0e6-89db-4ef0-b5ab-d6b3199bcfc42025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC668a2730-e95a-4639-a506-ae95a6502ca12025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
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
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
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMONESOURCE SPECIALTY PHARMA LIMITED28258745-12e4-4f0f-b318-4a1a1bebc9282025-07-21Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC9114cea1-3338-487e-87fa-cc3a409d501a2025-07-07Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMBluePoint Laboratories1aba753c-d0c2-4b35-917a-9143dd4be4682025-06-20Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.2c8f06a2-49b2-4169-94ef-182d13d248bf2025-05-21Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCc5cddf50-e486-4ffb-9bc6-ed67ad6bc1542025-04-14Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCa798faf5-cd97-4e35-a700-94c372978c462025-04-14Warnings, Adverse reactionsExact identifier
application number: ANDA203719
ndc (package): 65219-434-20
ndc (package): 65219-259-05
ndc (package): 65219-436-02
ndc (package): 65219-259-45
ndc (package): 65219-434-02
ndc (package): 65219-436-20
ndc (product): 65219-259
ndc (product): 65219-436
ndc (product): 65219-434
ndc11 (package): 65219025905
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
spl id: 76af03be-bc73-40f9-bde0-31fe9c359ca2
spl set id: a798faf5-cd97-4e35-a700-94c372978c46
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLC6a894b94-171f-4217-81a2-0e84796b0b412025-04-11Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCc8e3cc43-238d-4a23-95dc-157c85f831842025-04-10Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMProvepharm Inc.68d5384d-1691-4afc-8a1a-488f8e2ef2c52025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMProvepharm Inc.bc26ffd8-1a6e-4e16-91c1-ec67c928b3bf2025-02-26Warnings, Adverse reactionsExact identifier
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMSandoz Inc9b682c66-61c6-4ade-baf4-9d68911a16b82024-10-30Warnings, 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.