FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
65219-256
11-digit product format
652190256
Labeler code
65219
Product ID
65219-256_1c3dc47a-2988-4d82-8d64-eeaeb6083eba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203720
Marketing category
ANDA
Marketing start
2017-11-16
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
65219-256-00Piperacillin and Tazobactam180 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION1807
65219-256-00Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION17
65219-256-24Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
65219-256-24Piperacillin and Tazobactam180 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION1804
65219-256-28Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
65219-256-28Piperacillin and Tazobactam180 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-256PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20240217_c8e3cc43-238d-4a23-95dc-157c85f83184.zip
65219-256PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]3Current NDC, Legacy NDC, 2 package rows20240224_6a894b94-171f-4217-81a2-0e84796b0b41.zip
65219-256PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]3Current NDC, Legacy NDC, 2 package rows20240224_c5cddf50-e486-4ffb-9bc6-ed67ad6bc154.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNc8e3cc43-238d-4a23-95dc-157c85f831847
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDc8e3cc43-238d-4a23-95dc-157c85f831847
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYc8e3cc43-238d-4a23-95dc-157c85f831847
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN6a894b94-171f-4217-81a2-0e84796b0b414
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNc5cddf50-e486-4ffb-9bc6-ed67ad6bc1544
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD6a894b94-171f-4217-81a2-0e84796b0b414
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDc5cddf50-e486-4ffb-9bc6-ed67ad6bc1544
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY6a894b94-171f-4217-81a2-0e84796b0b414
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYc5cddf50-e486-4ffb-9bc6-ed67ad6bc1544

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65219-256-00652190256001 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65219-256-00) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE2017-11-160000-00-00NoNoCurrent
65219-256-24652190256241 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65219-256-24) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE2017-11-160000-00-00NoNoCurrent
65219-256-28652190256281 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65219-256-28) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE2017-11-160000-00-00NoNoCurrent