NDC 35369-0504-01 - 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: 35369-0504
Requested NDC: 35369-0504-01
Package NDCs from labels: 35369-0504-1, 35369-0504-01
Manufacturer: Shandong Anxin Pharmaceutical Co., Ltd.
Effective date: 2024-10-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Piperacillin and Tazobactam - Shandong Anxin Pharmaceutical Co., Ltd.	Shandong Anxin Pharmaceutical Co., Ltd.	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35369-0504-1	Piperacillin and Tazobactam	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		7
35369-0504-1	Piperacillin and Tazobactam	180 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, POWDER, LYOPHILIZED,	180		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35369-0504	PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHANDONG ANXIN PHARMACEUTICAL CO., LTD.]	7	Current NDC, 2 package rows	20241015_f817b9be-b12b-48ac-8e4e-57ef6812eb32.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piperacillin and Tazobactam	PIPERACILLIN SODIUM,TAZOBACTAM SODIUM	Fresenius Kabi USA, LLC	fc4d1e35-23eb-4654-8691-ae5bfd50a48a	2024-10-16	Warnings, Adverse reactions	Exact identifier unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM	Fresenius Kabi USA, LLC	e53ebafc-3afa-4a1e-9313-fecd1c1c5d7c	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312447 unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN SODIUM,TAZOBACTAM SODIUM	Fresenius Kabi USA, LLC	ba87ade3-4d41-40c0-9f6a-27e121a4136d	2024-10-16	Warnings, Adverse reactions	Exact identifier unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM	Fresenius Kabi USA, LLC	2cfa6723-175b-4c4d-8212-266844b07610	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312447 unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM	Fresenius Kabi USA, LLC	c78e0931-ec79-58e5-8658-7fe692dc3b8b	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312447 unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Apotex Corp.	c18109cf-d5db-4cc1-83da-537c8ab0e05c	2024-10-14	Warnings, Adverse reactions	Exact identifier application number: ANDA217243 rxcui: 312447 unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Shandong Anxin Pharmaceutical Co., Ltd.	f817b9be-b12b-48ac-8e4e-57ef6812eb32	2024-10-14	Warnings, Adverse reactions	Exact identifier application number: ANDA217243 ndc (package): 35369-0504-1 ndc (product): 35369-0504 ndc11 (package): 35369050401 rxcui: 312447 spl id: 7557a940-1967-4f48-8c56-d494b793d934 spl set id: f817b9be-b12b-48ac-8e4e-57ef6812eb32 unii: M98T69Q7HP unii: UXA545ABTT
piperacillin and tazobactam	PIPERACILLIN AND TAZOBACTAM	Armas Pharmaceuticals Inc.	24d9b4f1-109c-4db4-8a99-03afff045b47	2024-09-27	Warnings, Adverse reactions	Exact identifier unii: M98T69Q7HP unii: UXA545ABTT
piperacillin and tazobactam	PIPERACILLIN AND TAZOBACTAM	Armas Pharmaceuticals Inc.	bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a	2024-09-27	Warnings, Adverse reactions	Exact identifier unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM	Eugia US LLC	80f4bdb8-131e-4485-b7a2-accd596d4cde	2024-09-04	Warnings, Adverse reactions	Exact identifier rxcui: 312447 unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin, Tazobactam	PIPERACILLIN SODIUM, TAZOBACTAM SODIUM	Sagent Pharmaceuticals	83f4adcd-893c-4e9e-8f2b-e06299dcf34d	2024-08-31	Warnings, Adverse reactions	Exact identifier rxcui: 312447 unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Sandoz Inc	b1cb1314-d3e0-4b44-a1df-de14c32e8cc6	2024-08-23	Warnings, Adverse reactions	Exact identifier rxcui: 312447 unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Hospira, Inc	5e8bbfcd-3618-43ed-a158-9d524426fdc5	2024-08-23	Warnings, Adverse reactions	Exact identifier rxcui: 312447 unii: M98T69Q7HP unii: UXA545ABTT
Zosyn in Galaxy Containers	TAZOBACTAM SODIUM AND PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	8ab9d90d-2f7f-4599-a44f-3d0a8f8ab623	2023-03-15	Warnings, Adverse reactions	Exact identifier unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Fresenius Kabi USA, LLC	dc8208ea-a632-4291-a90b-2eba9a33bb40	2022-10-27	Warnings, Adverse reactions	Exact identifier unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Fresenius Kabi USA, LLC	b9bd733c-1176-42cb-b318-1223b7e48dcb	2021-05-19	Warnings, Adverse reactions	Exact identifier unii: M98T69Q7HP unii: UXA545ABTT
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Fresenius Kabi USA, LLC	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	2021-04-02	Warnings, Adverse reactions	Exact identifier unii: M98T69Q7HP unii: UXA545ABTT

Reported adverse events (FAERS/openFDA)#

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