FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
65219-434
11-digit product format
652190434
Labeler code
65219
Product ID
65219-434_76af03be-bc73-40f9-bde0-31fe9c359ca2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203719
Marketing category
ANDA
Marketing start
2023-03-20
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
2; .25 g/10mL; g/10mL
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 SODIUM2 g/10mL
TAZOBACTAM SODIUM.25 g/10mL

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
65219-434-02Piperacillin and Tazobactam10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,104
65219-434-20Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-434-02EA - Each65219-434c150079b-f859-4c4b-a0f4-36d650e0023f12023-12-05
65219-434-20EA - Each65219-434c30fe230-af15-46c1-801b-60262e3e8c7312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-434PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, 2 package rows20250516_a798faf5-cd97-4e35-a700-94c372978c46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSNa798faf5-cd97-4e35-a700-94c372978c464
1659137piperacillin / tazobactam 3.375 GM InjectionPSNa798faf5-cd97-4e35-a700-94c372978c464
1659149piperacillin / tazobactam 4.5 GM InjectionPSNa798faf5-cd97-4e35-a700-94c372978c464
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCDa798faf5-cd97-4e35-a700-94c372978c464
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCDa798faf5-cd97-4e35-a700-94c372978c464
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCDa798faf5-cd97-4e35-a700-94c372978c464
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSYa798faf5-cd97-4e35-a700-94c372978c464
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSYa798faf5-cd97-4e35-a700-94c372978c464
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSYa798faf5-cd97-4e35-a700-94c372978c464
1659131piperacillin / tazobactam 2.25 GM InjectionSYa798faf5-cd97-4e35-a700-94c372978c464
1659137piperacillin / tazobactam 3.375 GM InjectionSYa798faf5-cd97-4e35-a700-94c372978c464
1659149piperacillin / tazobactam 4.5 GM InjectionSYa798faf5-cd97-4e35-a700-94c372978c464

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-434-026521904340210 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
65219-434-206521904342010 VIAL, SINGLE-DOSE in 1 CARTON (65219-434-20) / 10 mL in 1 VIAL, SINGLE-DOSE (65219-434-02) 2023-03-20NoNoHistorical