FDA.reportPublic FDA data

piperacillin and tazobactam

Product NDC
72485-404
11-digit product format
724850404
Labeler code
72485
Product ID
72485-404_461fcd55-d5e4-d99d-e063-6394a90a77ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piperacillin and tazobactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA065458
Marketing category
ANDA
Marketing start
2022-04-14
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
4; .5 g/20mL; g/20mL
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 SODIUM4 g/20mL
TAZOBACTAM SODIUM.5 g/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM98T69Q7HP, UXA545ABTT
Rxcui1659149

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
72485-404-01piperacillin and tazobactam20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION206
72485-404-10piperacillin and tazobactam10 in 1 BOXINJECTION, POWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-404-01EA - Each72485-404e1e89e55-7ec0-4f69-bba8-21f74e467b5712022-06-06
72485-404-10EA - Each72485-40469f9b5ff-5472-4a15-acd4-9f497594123912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-404PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20241205_bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659149piperacillin / tazobactam 4.5 GM InjectionPSNbbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a6
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCDbbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a6
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSYbbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a6
1659149piperacillin / tazobactam 4.5 GM InjectionSYbbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-404-017248504040120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
72485-404-107248504041010 VIAL, SINGLE-DOSE in 1 BOX (72485-404-10) / 20 mL in 1 VIAL, SINGLE-DOSE (72485-404-01) 2022-04-140000-00-00NoNoCurrent