FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
0409-2999
11-digit product format
004092999
Labeler code
0409
Product ID
0409-2999_af500e36-42ae-496e-8e2c-caa5802ede7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; PARENTERAL
Labeler
Hospira, Inc
Application
ANDA203557
Marketing category
ANDA
Marketing start
2016-12-14
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
12; 1.5 g/60mL; g/60mL
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 SODIUM12 g/60mL
TAZOBACTAM SODIUM1.5 g/60mL

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
0409-2999-14Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,122
0409-2999-14Piperacillin and Tazobactam60 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2999-14EA - Each0409-29993c7350bd-614d-42d8-9c3c-703992f3265812017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2999PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC]21Current NDC, Legacy NDC, 2 package rows20241218_5e8bbfcd-3618-43ed-a158-9d524426fdc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN5e8bbfcd-3618-43ed-a158-9d524426fdc522
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD5e8bbfcd-3618-43ed-a158-9d524426fdc522
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY5e8bbfcd-3618-43ed-a158-9d524426fdc522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-2999-14004092999141 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-2999-14) / 60 mL in 1 VIAL, PHARMACY BULK PACKAGE2016-12-140000-00-00NoNoCurrent