FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
0781-3180
11-digit product format
007813180
Labeler code
0781
Product ID
0781-3180_27be0ff3-ee57-4d56-a73b-ca773d763a1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; PARENTERAL
Labeler
Sandoz Inc
Application
ANDA203557
Marketing category
ANDA
Marketing start
2021-10-25
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36; 4.5 g/250mL; g/250mL
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/250mL
TAZOBACTAM SODIUM4.5 g/250mL

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
0781-3180-94Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,124
0781-3180-94Piperacillin and Tazobactam250 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,25024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3180-94EA - Each0781-31807d7427f4-c6ee-42fc-b365-92e35fa2a02112021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3180PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]23Current NDC, Legacy NDC, 2 package rows20241228_b1cb1314-d3e0-4b44-a1df-de14c32e8cc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNb1cb1314-d3e0-4b44-a1df-de14c32e8cc624
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDb1cb1314-d3e0-4b44-a1df-de14c32e8cc624
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYb1cb1314-d3e0-4b44-a1df-de14c32e8cc624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3180-94007813180941 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3180-94) / 250 mL in 1 VIAL, PHARMACY BULK PACKAGE2021-10-250000-00-00NoNoCurrent