FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
35369-0503
11-digit product format
353690503
Labeler code
35369
Product ID
35369-0503_83e081fa-7103-403a-b275-7d7205835a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIPERACILLIN and TAZOBACTAM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Shandong Anxin Pharmaceutical Co., Ltd.
Application
ANDA204959
Marketing category
ANDA
Marketing start
2018-08-10
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
35369-0503-1Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION1510
35369-0503-2Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35369-0503PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [SHANDONG ANXIN PHARMACEUTICAL CO., LTD.]10Current NDC, Legacy NDC, 2 package rows20241019_420196a5-f62d-473f-84d8-d7fc3f31c3d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSN420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659137piperacillin / tazobactam 3.375 GM InjectionPSN420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659149piperacillin / tazobactam 4.5 GM InjectionPSN420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659131piperacillin / tazobactam 2.25 GM InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659137piperacillin / tazobactam 3.375 GM InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659149piperacillin / tazobactam 4.5 GM InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35369-0503-13536905030115 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical
35369-0503-23536905030210 VIAL, SINGLE-DOSE in 1 CARTON (35369-0503-2) / 15 mL in 1 VIAL, SINGLE-DOSE (35369-0503-1) 2018-08-100000-00-00NoNoCurrent