FDA.reportPublic FDA data

Piperacillin and Tazobactam and Sodium Chloride

Product NDC
0264-3450
11-digit product format
002643450
Labeler code
0264
Product ID
0264-3450_7c603d0f-caa7-4da2-a44b-dd19fa04b631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam and Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA206056
Marketing category
NDA
Marketing start
2025-09-30
Substance
TAZOBACTAM SODIUM; PIPERACILLIN SODIUM
Active strength
500; 4 mg/100mL; g/100mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206056-001PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINERPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03
N206056-002PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINERPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03
N206056-003PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINERPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N206056-001PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 2GM BASE/VIAL;EQ 250MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N206056-002PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 3GM BASE/VIAL;EQ 375MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-0384e616aacf4f…
2026-09-14 22:38:342026-08N206056-003PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 4GM BASE/VIAL;EQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-0384e616aacf4f…
2026-08-18 06:07:402026-07N206056-001PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 2GM BASE/VIAL;EQ 250MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N206056-002PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 3GM BASE/VIAL;EQ 375MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07N206056-003PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 4GM BASE/VIAL;EQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206056-001PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 2GM BASE/VIAL;EQ 250MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206056-002PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 3GM BASE/VIAL;EQ 375MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206056-003PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 4GM BASE/VIAL;EQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206056-001PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 2GM BASE/VIAL;EQ 250MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206056-002PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 3GM BASE/VIAL;EQ 375MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206056-003PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 4GM BASE/VIAL;EQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N206056-001PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 2GM BASE/VIAL;EQ 250MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206056-002PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 3GM BASE/VIAL;EQ 375MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206056-003PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 4GM BASE/VIAL;EQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206056-001PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 2GM BASE/VIAL;EQ 250MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206056-002PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 3GM BASE/VIAL;EQ 375MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206056-003PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 4GM BASE/VIAL;EQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-04-03a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Piperacillin and Tazobactam and Sodium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAZOBACTAM SODIUM500 mg/100mL
PIPERACILLIN SODIUM4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M98T69Q7HPInternal UNII lookup
UXA545ABTTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659131Internal RxNorm lookup
1659137Internal RxNorm lookup
1659149Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a63ca653-27d4-45fe-a744-77e0efe45220Available on FDA.report

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
0264-3450-22Piperacillin and Tazobactam and Sodium Chloride24 in 1 CASEINJECTION, SOLUTION2412
0264-3450-22Piperacillin and Tazobactam and Sodium Chloride100 mL in 1 CONTAINERINJECTION, SOLUTION10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3450-22EA - Each0264-3450050921ff-efca-47b4-a688-e37da072cbf222025-12-16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and Tazobactam and Sodium ChloridePIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDEB. Braun Medical Inc.a63ca653-27d4-45fe-a744-77e0efe452202026-05-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 206056
application number: NDA206056
ndc (product): 0264-3450

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSNa63ca653-27d4-45fe-a744-77e0efe4522012
1659137piperacillin / tazobactam 3.375 GM InjectionPSNa63ca653-27d4-45fe-a744-77e0efe4522012
1659149piperacillin / tazobactam 4.5 GM InjectionPSNa63ca653-27d4-45fe-a744-77e0efe4522012
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCDa63ca653-27d4-45fe-a744-77e0efe4522012
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCDa63ca653-27d4-45fe-a744-77e0efe4522012
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCDa63ca653-27d4-45fe-a744-77e0efe4522012
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659131piperacillin / tazobactam 2.25 GM InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659137piperacillin / tazobactam 3.375 GM InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012
1659149piperacillin / tazobactam 4.5 GM InjectionSYa63ca653-27d4-45fe-a744-77e0efe4522012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0264-3450-220026434502224 CONTAINER in 1 CASE (0264-3450-22) / 100 mL in 1 CONTAINER24 container2025-09-30NoNoCurrent