FDA.reportPublic FDA data

piperacillin and tazobactam

Product NDC
72485-403
11-digit product format
724850403
Labeler code
72485
Product ID
72485-403_461fc738-1117-cbbe-e063-6394a90af8de
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
3; .375 g/15mL; g/15mL
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 SODIUM3 g/15mL
TAZOBACTAM SODIUM.375 g/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM98T69Q7HP, UXA545ABTT
Rxcui1659137

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
72485-403-01piperacillin and tazobactam15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION154
72485-403-10piperacillin and tazobactam10 in 1 BOXINJECTION, POWDER, FOR SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-403-01EA - Each72485-4037bd03e30-7ab2-445a-92b3-e3b152a65ea612022-06-06
72485-403-10EA - Each72485-40306210d75-b763-406d-8931-a006b53c0af312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-403PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20241205_24d9b4f1-109c-4db4-8a99-03afff045b47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659137piperacillin / tazobactam 3.375 GM InjectionPSN24d9b4f1-109c-4db4-8a99-03afff045b474
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD24d9b4f1-109c-4db4-8a99-03afff045b474
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY24d9b4f1-109c-4db4-8a99-03afff045b474
1659137piperacillin / tazobactam 3.375 GM InjectionSY24d9b4f1-109c-4db4-8a99-03afff045b474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-403-017248504030115 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical
72485-403-107248504031010 VIAL, SINGLE-DOSE in 1 BOX (72485-403-10) / 15 mL in 1 VIAL, SINGLE-DOSE (72485-403-01) 2022-04-140000-00-00NoNoCurrent