FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
44567-804
11-digit product format
445670804
Labeler code
44567
Product ID
44567-804_9e491f95-a5aa-419e-a39f-159b64db9159
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA090498
Marketing category
ANDA
Marketing start
2009-10-20
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36; 4.5 g/1; g/1
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/1
TAZOBACTAM SODIUM4.5 g/1

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
44567-804-01Piperacillin and Tazobactam1 in 1 BOXINJECTION, POWDER, FOR SOLUTION113
44567-804-01Piperacillin and Tazobactam1 in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-804-01EA - Each44567-80447ec3628-0ab8-4e21-82e0-e441f17a5fed12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIPERACILLIN SODIUMACTIVE INGREDIENTM98T69Q7HPPIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]3
TAZOBACTAM SODIUMACTIVE INGREDIENTUXA545ABTTPIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]3
PIPERACILLIN ANHYDROUSACTIVE MOIETY9I628532GXPIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]3
TAZOBACTAMACTIVE MOIETYSE10G96M8WPIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-804PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]12Current NDC, Legacy NDC, 2 package rows20241206_17a400ae-cbaa-4d07-95f4-c6917dfc0585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN17a400ae-cbaa-4d07-95f4-c6917dfc058513
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD17a400ae-cbaa-4d07-95f4-c6917dfc058513
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY17a400ae-cbaa-4d07-95f4-c6917dfc058513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-804-01445670804011 BOTTLE in 1 BOX (44567-804-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE1 bottle2009-10-200000-00-00NoNoCurrent