FDA.reportPublic FDA data

NDC 67457-521-00 - 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
67457-521
Requested NDC
67457-521-00
Package NDCs from labels
67457-521-00, 67457-521-22
Manufacturer
Mylan Institutional LLC
Effective date
2020-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
piperacillin and tazobactam - Mylan Institutional LLCMylan Institutional LLC2020-07-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-521-00EA - Each67457-521f91a4816-1fc2-4f47-982c-76899d760bd012016-07-19
67457-521-22EA - Each67457-521c5fedce4-d5d5-46a9-8af3-4149e3d86d5112016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIPERACILLIN SODIUMACTIVE INGREDIENTM98T69Q7HPPIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]2
TAZOBACTAM SODIUMACTIVE INGREDIENTUXA545ABTTPIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]2
PIPERACILLIN ANHYDROUSACTIVE MOIETY9I628532GXPIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]2
TAZOBACTAMACTIVE MOIETYSE10G96M8WPIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]2

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 · 40 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
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
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMCivica, Inc.19e89f8b-316b-4dd2-9724-bfe0faeba4082025-12-12Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLC2cd82553-79dc-45f0-9755-2c08df524ed52025-10-31Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMCivica, Inc.7aebc0e6-89db-4ef0-b5ab-d6b3199bcfc42025-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA065458
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
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLCa5d8625e-e630-4076-bc55-46ebe861c6a52025-08-08Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMONESOURCE SPECIALTY PHARMA LIMITED28258745-12e4-4f0f-b318-4a1a1bebc9282025-07-21Warnings, Adverse reactionsExact identifier
application number: ANDA065458
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC9114cea1-3338-487e-87fa-cc3a409d501a2025-07-07Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMBluePoint Laboratories1aba753c-d0c2-4b35-917a-9143dd4be4682025-06-20Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.2c8f06a2-49b2-4169-94ef-182d13d248bf2025-05-21Warnings, Adverse reactionsExact identifier
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
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
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMSandoz Inc9b682c66-61c6-4ade-baf4-9d68911a16b82024-10-30Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT

Reported adverse events (FAERS/openFDA)#

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