Piperacillin and Tazobactam

Product NDC
83634-112
11-digit product format
836340112
Labeler code
83634
Product ID
83634-112_2f01070f-edc6-404f-bad8-1b0071c32b5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piperacillin and tazobactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy, LLC
Application
ANDA090498
Marketing category
ANDA
Marketing start
2025-09-01
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
83634-112-99Piperacillin and Tazobactam180 mL in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION1801
83634-112-99Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN668a2730-e95a-4639-a506-ae95a6502ca11
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD668a2730-e95a-4639-a506-ae95a6502ca11
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY668a2730-e95a-4639-a506-ae95a6502ca11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-112-99836340112991 BOTTLE in 1 CARTON (83634-112-99) / 180 mL in 1 BOTTLE1 bottle2025-09-01NoNoCurrent