FDA.reportPublic FDA data

Piperacillin and Tazobactam and Sodium Chloride

Product NDC
0264-3448
11-digit product format
002643448
Labeler code
0264
Product ID
0264-3448_7c603d0f-caa7-4da2-a44b-dd19fa04b631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam and Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA206056
Marketing category
NDA
Marketing start
2025-09-30
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
3; 375 g/50mL; mg/50mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Piperacillin and Tazobactam and Sodium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM3 g/50mL
TAZOBACTAM SODIUM375 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUXA545ABTT, M98T69Q7HP
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
0264-3448-11Piperacillin and Tazobactam and Sodium Chloride50 mL in 1 CONTAINERINJECTION, SOLUTION5012
0264-3448-11Piperacillin and Tazobactam and Sodium Chloride24 in 1 CASEINJECTION, SOLUTION2412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3448-11EA - Each0264-34487e9726bb-713f-4005-96c6-11722eac1b6a22025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSNa63ca653-27d4-45fe-a744-77e0efe4522012
1659137piperacillin / tazobactam 3.375 GM InjectionPSNa63ca653-27d4-45fe-a744-77e0efe4522012
1659149piperacillin / tazobactam 4.5 GM InjectionPSNa63ca653-27d4-45fe-a744-77e0efe4522012
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCDa63ca653-27d4-45fe-a744-77e0efe4522012
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCDa63ca653-27d4-45fe-a744-77e0efe4522012
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCDa63ca653-27d4-45fe-a744-77e0efe4522012
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659131piperacillin / tazobactam 2.25 GM InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659137piperacillin / tazobactam 3.375 GM InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659149piperacillin / tazobactam 4.5 GM InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0264-3448-110026434481124 CONTAINER in 1 CASE (0264-3448-11) / 50 mL in 1 CONTAINER24 container2025-09-30NoNoHistorical