Piperacillin and Tazobactam

Product NDC
44567-804
11-digit product format
445670804
Labeler code
44567
Product ID
44567-804_9e491f95-a5aa-419e-a39f-159b64db9159
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA090498
Marketing category
ANDA
Marketing start
2009-10-20
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36; 4.5 g/1; g/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090498-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090498-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090498-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2011-05-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090498-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090498-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090498-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090498-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090498-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090498-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090498-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090498-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090498-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090498-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090498-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090498-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090498-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090498-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090498-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090498-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090498-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090498-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090498-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090498-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090498-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A090498-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090498-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090498-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090498-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A090498-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090498-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090498-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090498-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090498-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090498-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090498-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090498-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090498-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090498-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090498-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090498-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090498-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090498-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090498-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM36 g/1
TAZOBACTAM SODIUM4.5 g/1

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312447Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
17a400ae-cbaa-4d07-95f4-c6917dfc0585Available 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
44567-804-01Piperacillin and Tazobactam1 in 1 BOXINJECTION, POWDER, FOR SOLUTION113
44567-804-01Piperacillin and Tazobactam1 in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-804-01EA - Each44567-80447ec3628-0ab8-4e21-82e0-e441f17a5fed12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-804PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]12Current NDC, Legacy NDC, 2 package rows20241206_17a400ae-cbaa-4d07-95f4-c6917dfc0585.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMWG Critical Care, LLC17a400ae-cbaa-4d07-95f4-c6917dfc05852026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090498
application number: ANDA090498
ndc (product): 44567-804
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC668a2730-e95a-4639-a506-ae95a6502ca12025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090498
application number: ANDA090498
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLCe53ebafc-3afa-4a1e-9313-fecd1c1c5d7c2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090498
application number: ANDA090498
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLC2cfa6723-175b-4c4d-8212-266844b076102024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090498
application number: ANDA090498
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMFresenius Kabi USA, LLCc78e0931-ec79-58e5-8658-7fe692dc3b8b2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090498
application number: ANDA090498

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN17a400ae-cbaa-4d07-95f4-c6917dfc058513
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD17a400ae-cbaa-4d07-95f4-c6917dfc058513
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY17a400ae-cbaa-4d07-95f4-c6917dfc058513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-804-01445670804011 BOTTLE in 1 BOX (44567-804-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE1 bottle2009-10-200000-00-00NoNoCurrent