FDA.reportPublic FDA data

NDC 67457-522-00 - 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
67457-522
Requested NDC
67457-522-00
Package NDCs from labels
67457-522-00, 67457-522-37
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
67457-522-00EA - Each67457-5226c3fff0a-727f-419c-8f77-430b914db6e112015-09-10
67457-522-37EA - Each67457-5227264fb62-8d9f-4771-a7c3-a2a3417d337112015-09-10

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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCfc4d1e35-23eb-4654-8691-ae5bfd50a48a2024-10-16Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLCe53ebafc-3afa-4a1e-9313-fecd1c1c5d7c2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCba87ade3-4d41-40c0-9f6a-27e121a4136d2024-10-16Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLC2cfa6723-175b-4c4d-8212-266844b076102024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLCc78e0931-ec79-58e5-8658-7fe692dc3b8b2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.c18109cf-d5db-4cc1-83da-537c8ab0e05c2024-10-14Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMShandong Anxin Pharmaceutical Co., Ltd.f817b9be-b12b-48ac-8e4e-57ef6812eb322024-10-14Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMArmas Pharmaceuticals Inc.24d9b4f1-109c-4db4-8a99-03afff045b472024-09-27Warnings, Adverse reactionsExact identifier
application number: ANDA065458
unii: M98T69Q7HP
unii: UXA545ABTT
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMArmas Pharmaceuticals Inc.bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a2024-09-27Warnings, Adverse reactionsExact identifier
application number: ANDA065458
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLC80f4bdb8-131e-4485-b7a2-accd596d4cde2024-09-04Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin, TazobactamPIPERACILLIN SODIUM, TAZOBACTAM SODIUMSagent Pharmaceuticals83f4adcd-893c-4e9e-8f2b-e06299dcf34d2024-08-31Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMSandoz Incb1cb1314-d3e0-4b44-a1df-de14c32e8cc62024-08-23Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMHospira, Inc5e8bbfcd-3618-43ed-a158-9d524426fdc52024-08-23Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
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
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCdc8208ea-a632-4291-a90b-2eba9a33bb402022-10-27Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCb9bd733c-1176-42cb-b318-1223b7e48dcb2021-05-19Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLC1eb40c84-0cb3-4648-a39f-f4ebc4dbcb162021-04-02Warnings, Adverse reactionsExact identifier
unii: M98T69Q7HP
unii: UXA545ABTT
3921ae66-d2c1-413f-b848-47fa2ef20d14e4cd6d4a-920b-41dc-a4ad-e0c7fc68b2e32020-07-14Warnings, Adverse reactionsExact identifier
spl id: 3921ae66-d2c1-413f-b848-47fa2ef20d14
spl set id: e4cd6d4a-920b-41dc-a4ad-e0c7fc68b2e3

Reported adverse events (FAERS/openFDA)#

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