FDA.reportPublic FDA data

PIPERACILLIN AND TAZOBACTAM

Product NDC
81284-151
11-digit product format
812840151
Labeler code
81284
Product ID
81284-151_5e55a3fe-170f-4509-a4dd-307a6b24fc71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin sodium and Tazobactam sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Provepharm Inc.
Application
ANDA207847
Marketing category
ANDA
Marketing start
2019-08-01
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
2; .25 g/10mL; g/10mL
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 SODIUM2 g/10mL
TAZOBACTAM SODIUM.25 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUXA545ABTT, M98T69Q7HP
Rxcui1659131, 1659137, 1659149

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
81284-151-00PIPERACILLIN AND TAZOBACTAM10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,106
81284-151-10PIPERACILLIN AND TAZOBACTAM10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81284-151-00EA - Each81284-151aed08c2a-de4c-4dd8-82ef-1541d42c762312023-01-09
81284-151-10EA - Each81284-151fb2fc320-9ff5-4dc6-b330-901ee2bf5e7a12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81284-151PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROVEPHARM INC.]6Current NDC, Legacy NDC, 2 package rows20250305_bc26ffd8-1a6e-4e16-91c1-ec67c928b3bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSNbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659137piperacillin / tazobactam 3.375 GM InjectionPSNbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659149piperacillin / tazobactam 4.5 GM InjectionPSNbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCDbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCDbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCDbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSYbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSYbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSYbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659131piperacillin / tazobactam 2.25 GM InjectionSYbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659137piperacillin / tazobactam 3.375 GM InjectionSYbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6
1659149piperacillin / tazobactam 4.5 GM InjectionSYbc26ffd8-1a6e-4e16-91c1-ec67c928b3bf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81284-151-008128401510010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
81284-151-108128401511010 VIAL, SINGLE-DOSE in 1 CARTON (81284-151-10) / 10 mL in 1 VIAL, SINGLE-DOSE (81284-151-00) 2019-08-010000-00-00NoNoCurrent