FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
60505-6159
11-digit product format
605056159
Labeler code
60505
Product ID
60505-6159_0702bfe3-61ba-4c3e-a9e4-ceafca2a8821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIPERACILLIN and TAZOBACTAM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA204959
Marketing category
ANDA
Marketing start
2019-03-15
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
4; .5 g/20mL; g/20mL
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 SODIUM4 g/20mL
TAZOBACTAM SODIUM.5 g/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM98T69Q7HP, UXA545ABTT
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
60505-6159-0Piperacillin and Tazobactam20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION2012
60505-6159-4Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6159-0EA - Each60505-6159351fb280-943e-40f1-b765-1428928b054a12019-03-12
60505-6159-4EA - Each60505-6159c36514c7-9ffe-49fc-92f4-88bdba0a43b412019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6159PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]12Current NDC, Legacy NDC, 2 package rows20250523_2c8f06a2-49b2-4169-94ef-182d13d248bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSN2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659137piperacillin / tazobactam 3.375 GM InjectionPSN2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659149piperacillin / tazobactam 4.5 GM InjectionPSN2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659131piperacillin / tazobactam 2.25 GM InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659137piperacillin / tazobactam 3.375 GM InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659149piperacillin / tazobactam 4.5 GM InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-6159-06050561590020 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
60505-6159-46050561590410 VIAL, SINGLE-DOSE in 1 CARTON (60505-6159-4) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6159-0) 2019-03-150000-00-00NoNoCurrent