FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
60505-6262
11-digit product format
605056262
Labeler code
60505
Product ID
60505-6262_36e76c91-4d5f-402d-addd-eef8d5cef887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA217243
Marketing category
ANDA
Marketing start
2023-09-26
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
60505-6262-0Piperacillin and Tazobactam180 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,1804
60505-6262-0Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6262-0EA - Each60505-6262156a19a6-4f64-4f9c-960f-1260055c211012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6262PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP.]4Current NDC, 2 package rows20241015_c18109cf-d5db-4cc1-83da-537c8ab0e05c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNc18109cf-d5db-4cc1-83da-537c8ab0e05c4
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDc18109cf-d5db-4cc1-83da-537c8ab0e05c4
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYc18109cf-d5db-4cc1-83da-537c8ab0e05c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6262-0605056262001 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6262-0) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE2023-09-26NoNoCurrent