FDA.reportPublic FDA data

NDC 63323-983-41 - 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
63323-983
Requested NDC
63323-983-41
Package NDCs from labels
63323-983-23, 63323-983-21, 63323-983-41, 63323-983-53
Manufacturer
Fresenius Kabi USA, LLC | Haupt Pharma Latina S.r.l.
Effective date
2022-10-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PIPERACILLIN SODIUM - Fresenius Kabi USA, LLC | Haupt Pharma Latina S.r.l.Fresenius Kabi USA, LLC | Haupt Pharma Latina S.r.l.2022-10-27HUMAN PRESCRIPTION DRUG LABEL
PIPERACILLIN SODIUM - Fresenius Kabi USA, LLC | Haupt Pharma Latina S.r.l.Fresenius Kabi USA, LLC | Haupt Pharma Latina S.r.l.2021-04-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-983-21Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106
63323-983-23Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,156
63323-983-41Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,154
63323-983-53Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-983PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20221104_dc8208ea-a632-4291-a90b-2eba9a33bb40.zip
63323-983PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20221029_1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-983-21EA - Each63323-983ae777587-341b-4ddd-9597-987ad8c8803912019-08-06
63323-983-23EA - Each63323-9834f6bdde7-be64-4c2a-b03c-f8f5b70cd64712019-08-06
63323-983-41EA - Each63323-983ae1b80e7-2ffc-4c8c-89f0-8a197958d7ee12019-10-07
63323-983-53EA - Each63323-98375fe8371-7d0c-4c38-ab18-3f2c47c7c39f12019-10-07

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 2 of 2 · 37 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
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
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
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
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
rxcui: 1659137
unii: M98T69Q7HP
unii: UXA545ABTT
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMArmas Pharmaceuticals Inc.bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a2024-09-27Warnings, Adverse reactionsExact identifier
rxcui: 1659149
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
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCdc8208ea-a632-4291-a90b-2eba9a33bb402022-10-27Warnings, Adverse reactionsExact identifier
application number: ANDA203719
ndc (package): 63323-982-52
ndc (package): 63323-982-21
ndc (package): 63323-983-23
ndc (package): 63323-983-21
ndc (package): 63323-981-21
ndc (package): 63323-981-23
ndc (product): 63323-983
ndc (product): 63323-982
ndc (product): 63323-981
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
spl id: 0802b499-4d2a-43ad-8fea-ad80b6738a46
spl set id: dc8208ea-a632-4291-a90b-2eba9a33bb40
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCb9bd733c-1176-42cb-b318-1223b7e48dcb2021-05-19Warnings, Adverse reactionsExact identifier
application number: ANDA203719
rxcui: 1659149
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLC1eb40c84-0cb3-4648-a39f-f4ebc4dbcb162021-04-02Warnings, Adverse reactionsExact identifier
application number: ANDA203719
ndc (package): 63323-981-41
ndc (package): 63323-982-43
ndc (package): 63323-981-53
ndc (package): 63323-983-41
ndc (package): 63323-983-53
ndc (package): 63323-982-54
ndc (product): 63323-983
ndc (product): 63323-982
ndc (product): 63323-981
ndc11 (package): 63323098341
rxcui: 1659137
rxcui: 1659131
rxcui: 1659149
spl id: 6487ad37-921c-4994-bef4-38854cdecec9
spl set id: 1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16
unii: M98T69Q7HP
unii: UXA545ABTT

Reported adverse events (FAERS/openFDA)#

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