FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
83634-105
11-digit product format
836340105
Labeler code
83634
Product ID
83634-105_2e787de2-4294-4caf-9f68-fa65e574eede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piperacillin and tazobactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy, LLC
Application
ANDA065523
Marketing category
ANDA
Marketing start
2025-02-01
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
3; .375 g/15mL; g/15mL
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 SODIUM3 g/15mL
TAZOBACTAM SODIUM.375 g/15mL

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
83634-105-30Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102
83634-105-41Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-105PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [AVENACY INC.]1Current NDC, 2 package rows20250201_9114cea1-3338-487e-87fa-cc3a409d501a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSN9114cea1-3338-487e-87fa-cc3a409d501a2
1659137piperacillin / tazobactam 3.375 GM InjectionPSN9114cea1-3338-487e-87fa-cc3a409d501a2
1659149piperacillin / tazobactam 4.5 GM InjectionPSN9114cea1-3338-487e-87fa-cc3a409d501a2
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD9114cea1-3338-487e-87fa-cc3a409d501a2
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD9114cea1-3338-487e-87fa-cc3a409d501a2
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD9114cea1-3338-487e-87fa-cc3a409d501a2
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY9114cea1-3338-487e-87fa-cc3a409d501a2
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY9114cea1-3338-487e-87fa-cc3a409d501a2
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY9114cea1-3338-487e-87fa-cc3a409d501a2
1659131piperacillin / tazobactam 2.25 GM InjectionSY9114cea1-3338-487e-87fa-cc3a409d501a2
1659137piperacillin / tazobactam 3.375 GM InjectionSY9114cea1-3338-487e-87fa-cc3a409d501a2
1659149piperacillin / tazobactam 4.5 GM InjectionSY9114cea1-3338-487e-87fa-cc3a409d501a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-105-308363401053010 VIAL, SINGLE-DOSE in 1 CARTON (83634-105-30) / 15 mL in 1 VIAL, SINGLE-DOSE (83634-105-41) 2025-02-01NoNoCurrent
83634-105-418363401054115 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical