FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
44567-803
11-digit product format
445670803
Labeler code
44567
Product ID
44567-803_2eb617c2-c198-4e3a-bccd-68616e26a5d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIPERACILLIN SODIUM,TAZOBACTAM SODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065523
Marketing category
ANDA
Marketing start
2009-10-13
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
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 SODIUM4 g/1
TAZOBACTAM SODIUM.5 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM98T69Q7HP, UXA545ABTT
Rxcui1659131, 1659137, 1659149

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
44567-803-10Piperacillin and Tazobactam10 in 1 BOXINJECTION, POWDER, FOR SOLUTION1013
44567-803-10Piperacillin and Tazobactam1 in 1 VIALINJECTION, POWDER, FOR SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-803-10EA - Each44567-80382d61c26-cc7f-4d09-9fc1-c43383c60a3112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIPERACILLIN SODIUMACTIVE INGREDIENTM98T69Q7HPPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM,TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]4
TAZOBACTAM SODIUMACTIVE INGREDIENTUXA545ABTTPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM,TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]4
PIPERACILLIN ANHYDROUSACTIVE MOIETY9I628532GXPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM,TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]4
TAZOBACTAMACTIVE MOIETYSE10G96M8WPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM,TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-803PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM,TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]13Current NDC, Legacy NDC, 2 package rows20241206_2cd82553-79dc-45f0-9755-2c08df524ed5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSN2cd82553-79dc-45f0-9755-2c08df524ed513
1659137piperacillin / tazobactam 3.375 GM InjectionPSN2cd82553-79dc-45f0-9755-2c08df524ed513
1659149piperacillin / tazobactam 4.5 GM InjectionPSN2cd82553-79dc-45f0-9755-2c08df524ed513
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD2cd82553-79dc-45f0-9755-2c08df524ed513
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD2cd82553-79dc-45f0-9755-2c08df524ed513
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD2cd82553-79dc-45f0-9755-2c08df524ed513
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY2cd82553-79dc-45f0-9755-2c08df524ed513
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY2cd82553-79dc-45f0-9755-2c08df524ed513
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY2cd82553-79dc-45f0-9755-2c08df524ed513
1659131piperacillin / tazobactam 2.25 GM InjectionSY2cd82553-79dc-45f0-9755-2c08df524ed513
1659137piperacillin / tazobactam 3.375 GM InjectionSY2cd82553-79dc-45f0-9755-2c08df524ed513
1659149piperacillin / tazobactam 4.5 GM InjectionSY2cd82553-79dc-45f0-9755-2c08df524ed513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-803-104456708031010 VIAL in 1 BOX (44567-803-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2009-10-130000-00-00NoNoCurrent