FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
55150-473
11-digit product format
551500473
Labeler code
55150
Product ID
55150-473_d55bf2c9-ae5b-4a09-8151-9ba0046a7d3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin Sodium and Tazobactam Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA217409
Marketing category
ANDA
Marketing start
2023-10-12
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36; 4.5 g/250mL; g/250mL
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/250mL
TAZOBACTAM SODIUM4.5 g/250mL

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
55150-473-01Piperacillin and Tazobactam152 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,1523
55150-473-01Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-473PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]3Current NDC, 2 package rows20240907_80f4bdb8-131e-4485-b7a2-accd596d4cde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN80f4bdb8-131e-4485-b7a2-accd596d4cde3
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD80f4bdb8-131e-4485-b7a2-accd596d4cde3
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY80f4bdb8-131e-4485-b7a2-accd596d4cde3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55150-473-01551500473011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-473-01) / 152 mL in 1 VIAL, PHARMACY BULK PACKAGE2023-10-12NoNoHistorical