FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
72572-573
11-digit product format
725720573
Labeler code
72572
Product ID
72572-573_7bc55307-0d44-4b72-a698-2483af36ff51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piperacillin sodium and tazobactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA065523
Marketing category
ANDA
Marketing start
2020-12-01
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
UniiM98T69Q7HP, UXA545ABTT
Rxcui1659137, 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
72572-573-01Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION157
72572-573-10Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-573-01EA - Each72572-5733834117c-2fab-4631-8c37-f7602d77664012021-01-08
72572-573-10EA - Each72572-5734a883a37-a63a-4d23-add2-73eaf83b69be12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-573PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.]6Current NDC, Legacy NDC, 2 package rows20241108_19e89f8b-316b-4dd2-9724-bfe0faeba408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659137piperacillin / tazobactam 3.375 GM InjectionPSN19e89f8b-316b-4dd2-9724-bfe0faeba4087
1659149piperacillin / tazobactam 4.5 GM InjectionPSN19e89f8b-316b-4dd2-9724-bfe0faeba4087
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD19e89f8b-316b-4dd2-9724-bfe0faeba4087
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD19e89f8b-316b-4dd2-9724-bfe0faeba4087
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY19e89f8b-316b-4dd2-9724-bfe0faeba4087
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY19e89f8b-316b-4dd2-9724-bfe0faeba4087
1659137piperacillin / tazobactam 3.375 GM InjectionSY19e89f8b-316b-4dd2-9724-bfe0faeba4087
1659149piperacillin / tazobactam 4.5 GM InjectionSY19e89f8b-316b-4dd2-9724-bfe0faeba4087

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-573-017257205730115 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical
72572-573-107257205731010 VIAL, SINGLE-DOSE in 1 CARTON (72572-573-10) / 15 mL in 1 VIAL, SINGLE-DOSE (72572-573-01) 2020-12-010000-00-00NoNoCurrent