FDA.reportPublic FDA data

Piperacillin, Tazobactam

Product NDC
25021-181
11-digit product format
250210181
Labeler code
25021
Product ID
25021-181_a6724256-14c5-4408-83a5-a964f146f0d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin Sodium, Tazobactam Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA208675
Marketing category
ANDA
Marketing start
2021-02-28
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36; 4.5 g/152mL; g/152mL
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, Tazobactam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM36 g/152mL
TAZOBACTAM SODIUM4.5 g/152mL

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
25021-181-99Piperacillin, Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,114
25021-181-99Piperacillin, Tazobactam152 mL in 1 BOTTLEINJECTION, POWDER, LYOPHILIZED,15214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-181-99EA - Each25021-181ac169699-2bc9-44e4-8ac3-3e023f4cbbac12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-181PIPERACILLIN, TAZOBACTAM (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]14Current NDC, Legacy NDC, 2 package rows20241120_83f4adcd-893c-4e9e-8f2b-e06299dcf34d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN83f4adcd-893c-4e9e-8f2b-e06299dcf34d14
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD83f4adcd-893c-4e9e-8f2b-e06299dcf34d14
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY83f4adcd-893c-4e9e-8f2b-e06299dcf34d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-181-99250210181991 BOTTLE in 1 CARTON (25021-181-99) / 152 mL in 1 BOTTLE1 bottle2021-02-280000-00-00NoNoCurrent