FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
35369-0504
11-digit product format
353690504
Labeler code
35369
Product ID
35369-0504_7557a940-1967-4f48-8c56-d494b793d934
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Shandong Anxin Pharmaceutical Co., Ltd.
Application
ANDA217243
Marketing category
ANDA
Marketing start
2023-04-14
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36; 4.5 g/180mL; g/180mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Piperacillin and Tazobactam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM36 g/180mL
TAZOBACTAM SODIUM4.5 g/180mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM98T69Q7HP, UXA545ABTT
Rxcui312447

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5fa255cf-091e-4504-8ebf-eef4259776e8Product name120260112
a6bfe911-d09e-4049-bcde-a3213184a72cProduct name820240501
61877847-a958-4874-a7cf-2bbeff51a37bProduct name220180717
e0d9b1cf-1fe5-42a8-b30f-70b3a7bd8d22Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35369-0504-1Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
35369-0504-1Piperacillin and Tazobactam180 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35369-0504PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHANDONG ANXIN PHARMACEUTICAL CO., LTD.]7Current NDC, 2 package rows20241015_f817b9be-b12b-48ac-8e4e-57ef6812eb32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNf817b9be-b12b-48ac-8e4e-57ef6812eb327
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDf817b9be-b12b-48ac-8e4e-57ef6812eb327
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYf817b9be-b12b-48ac-8e4e-57ef6812eb327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
35369-0504-1353690504011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (35369-0504-1) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE2023-04-14NoNoCurrent