Piperacillin and Tazobactam

Product NDC
35369-0502
11-digit product format
353690502
Labeler code
35369
Product ID
35369-0502_83e081fa-7103-403a-b275-7d7205835a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIPERACILLIN and TAZOBACTAM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Shandong Anxin Pharmaceutical Co., Ltd.
Application
ANDA204959
Marketing category
ANDA
Marketing start
2018-08-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204959-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10
A204959-002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10
A204959-003PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204959-001AP
A204959-002AP
A204959-003AP

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204959-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204959-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204959-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204959-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204959-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204959-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204959-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204959-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204959-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204959-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204959-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204959-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204959-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204959-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204959-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204959-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204959-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204959-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204959-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204959-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204959-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204959-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204959-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204959-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204959-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204959-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204959-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204959-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204959-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204959-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204959-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204959-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204959-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204959-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204959-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204959-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204959-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204959-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204959-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204959-001AP18072bd15b7f6…

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 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
420196a5-f62d-473f-84d8-d7fc3f31c3d3Available 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
35369-0502-1Piperacillin and Tazobactam10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION1010
35369-0502-2Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35369-0502PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [SHANDONG ANXIN PHARMACEUTICAL CO., LTD.]10Current NDC, Legacy NDC, 2 package rows20241019_420196a5-f62d-473f-84d8-d7fc3f31c3d3.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMBluePoint Laboratories1aba753c-d0c2-4b35-917a-9143dd4be4682025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204959
application number: ANDA204959
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.2c8f06a2-49b2-4169-94ef-182d13d248bf2025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204959
application number: ANDA204959
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMShandong Anxin Pharmaceutical Co., Ltd.420196a5-f62d-473f-84d8-d7fc3f31c3d32024-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204959
application number: ANDA204959
ndc (product): 35369-0502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSN420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659137piperacillin / tazobactam 3.375 GM InjectionPSN420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659149piperacillin / tazobactam 4.5 GM InjectionPSN420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659131piperacillin / tazobactam 2.25 GM InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659137piperacillin / tazobactam 3.375 GM InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310
1659149piperacillin / tazobactam 4.5 GM InjectionSY420196a5-f62d-473f-84d8-d7fc3f31c3d310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35369-0502-13536905020110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
35369-0502-23536905020210 VIAL, SINGLE-DOSE in 1 CARTON (35369-0502-2) / 10 mL in 1 VIAL, SINGLE-DOSE (35369-0502-1) 2018-08-100000-00-00NoNoCurrent