piperacillin and tazobactam

Product NDC
72485-404
Requested package NDC
72485-404-10
11-digit product format
724850404
Labeler code
72485
Product ID
72485-404_461fcd55-d5e4-d99d-e063-6394a90a77ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piperacillin and tazobactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA065458
Marketing category
ANDA
Marketing start
2022-04-14
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
4; .5 g/20mL; g/20mL
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
A065458-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15
A065458-002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15
A065458-003PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065458-001AP
A065458-002AP
A065458-003AP

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 UTC2026-02A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065458-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065458-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065458-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2014-08-158072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065458-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065458-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065458-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065458-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065458-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065458-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065458-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065458-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065458-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065458-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065458-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065458-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065458-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065458-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065458-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065458-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065458-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065458-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065458-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065458-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065458-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065458-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065458-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065458-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065458-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065458-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065458-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065458-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065458-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065458-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065458-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065458-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065458-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065458-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065458-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065458-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065458-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065458-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065458-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065458-001AP18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
piperacillin and tazobactam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM4 g/20mL
TAZOBACTAM SODIUM.5 g/20mL

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
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
bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2aAvailable 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
72485-404-01piperacillin and tazobactam20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION206
72485-404-10piperacillin and tazobactam10 in 1 BOXINJECTION, POWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-404-01EA - Each72485-404e1e89e55-7ec0-4f69-bba8-21f74e467b5712022-06-06
72485-404-10EA - Each72485-40469f9b5ff-5472-4a15-acd4-9f497594123912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-404PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20241205_bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMCivica, Inc.7aebc0e6-89db-4ef0-b5ab-d6b3199bcfc42025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065458
application number: ANDA065458
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMONESOURCE SPECIALTY PHARMA LIMITED28258745-12e4-4f0f-b318-4a1a1bebc9282025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065458
application number: ANDA065458
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMArmas Pharmaceuticals Inc.24d9b4f1-109c-4db4-8a99-03afff045b472024-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065458
application number: ANDA065458
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMArmas Pharmaceuticals Inc.bbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a2024-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065458
application number: ANDA065458
ndc (package): 72485-404-10
ndc (product): 72485-404
ndc11 (package): 72485040410

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659149piperacillin / tazobactam 4.5 GM InjectionPSNbbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a6
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCDbbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a6
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSYbbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a6
1659149piperacillin / tazobactam 4.5 GM InjectionSYbbd1e6ae-e19a-4572-a0ec-e78c8aa31d2a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72485-404-107248504041010 VIAL, SINGLE-DOSE in 1 BOX (72485-404-10) / 20 mL in 1 VIAL, SINGLE-DOSE (72485-404-01) 2022-04-140000-00-00NoNoCurrent