Piperacillin and Tazobactam

Product NDC
0781-3180
11-digit product format
007813180
Labeler code
0781
Product ID
0781-3180_27be0ff3-ee57-4d56-a73b-ca773d763a1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; PARENTERAL
Labeler
Sandoz Inc
Application
ANDA203557
Marketing category
ANDA
Marketing start
2021-10-25
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36; 4.5 g/250mL; g/250mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203557-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-29
A203557-002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203557-001AP
A203557-002AP

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-2984e616aacf4f…
2026-09-14 22:38:342026-08A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-0884e616aacf4f…
2026-08-18 06:07:402026-07A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2014-10-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2014-10-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2014-10-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2014-10-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203557-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2021-07-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2014-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203557-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2014-10-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203557-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A203557-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A203557-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203557-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203557-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203557-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203557-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203557-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203557-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203557-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203557-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203557-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203557-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203557-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203557-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203557-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203557-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203557-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203557-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203557-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203557-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203557-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203557-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203557-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203557-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203557-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203557-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203557-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203557-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203557-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203557-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203557-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203557-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203557-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203557-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203557-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203557-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203557-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203557-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203557-001AP1bb7c543d1eb4…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM36 g/250mL
TAZOBACTAM SODIUM4.5 g/250mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UXA545ABTTInternal UNII lookup
M98T69Q7HPInternal 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
b1cb1314-d3e0-4b44-a1df-de14c32e8cc6Available 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
0781-3180-94Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,124
0781-3180-94Piperacillin and Tazobactam250 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,25024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3180-94EA - Each0781-31807d7427f4-c6ee-42fc-b365-92e35fa2a02112021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3180PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]23Current NDC, Legacy NDC, 2 package rows20241228_b1cb1314-d3e0-4b44-a1df-de14c32e8cc6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMSandoz Incb1cb1314-d3e0-4b44-a1df-de14c32e8cc62024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203557
application number: ANDA203557
ndc (product): 0781-3180
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMHospira, Inc5e8bbfcd-3618-43ed-a158-9d524426fdc52024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203557
application number: ANDA203557

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNb1cb1314-d3e0-4b44-a1df-de14c32e8cc624
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDb1cb1314-d3e0-4b44-a1df-de14c32e8cc624
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYb1cb1314-d3e0-4b44-a1df-de14c32e8cc624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3180-94007813180941 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3180-94) / 250 mL in 1 VIAL, PHARMACY BULK PACKAGE2021-10-250000-00-00NoNoCurrent