NDC 72485-403-01 - 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
72485-403
Requested NDC
72485-403-01
Package NDCs from labels
72485-403-01, 72485-403-10
Manufacturer
Armas Pharmaceuticals Inc. | Onesource Specialty Pte. Limited | Steriscience Specialties Private Limited
Effective date
2024-09-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PIPERACILLIN SODIUM - Armas Pharmaceuticals Inc. | Onesource Specialty Pte. Limited | Steriscience Specialties Private LimitedArmas Pharmaceuticals Inc. | Onesource Specialty Pte. Limited | Steriscience Specialties Private Limited2024-09-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-403-01piperacillin and tazobactam15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION154
72485-403-10piperacillin and tazobactam10 in 1 BOXINJECTION, POWDER, FOR SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-403PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20241205_24d9b4f1-109c-4db4-8a99-03afff045b47.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-403-01EA - Each72485-4037bd03e30-7ab2-445a-92b3-e3b152a65ea612022-06-06
72485-403-10EA - Each72485-40306210d75-b763-406d-8931-a006b53c0af312022-06-06

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
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
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
ndc (package): 72485-403-10
ndc (package): 72485-403-01
ndc (product): 72485-403
ndc11 (package): 72485040301
rxcui: 1659137
spl id: 461fc738-1117-cbbe-e063-6394a90af8de
spl set id: 24d9b4f1-109c-4db4-8a99-03afff045b47
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
rxcui: 1659137
unii: M98T69Q7HP
unii: UXA545ABTT
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCdc8208ea-a632-4291-a90b-2eba9a33bb402022-10-27Warnings, Adverse reactionsExact identifier
rxcui: 1659137
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
rxcui: 1659137
unii: M98T69Q7HP
unii: UXA545ABTT

Reported adverse events (FAERS/openFDA)#

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