Piperacillin, Tazobactam

Product NDC
25021-166
Requested package NDC
25021-166-48
11-digit product format
250210166
Labeler code
25021
Product ID
25021-166_66203cc2-0948-4012-ae96-532463e614a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin Sodium, Tazobactam Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA065498
Marketing category
ANDA
Marketing start
2011-06-16
Marketing end
2022-12-31
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
4 g/20mL; g/20mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage25021-16625021-166-48DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A065498-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23
A065498-002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23
A065498-003PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065498-001AP
A065498-002AP
A065498-003AP

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 UTC2026-02A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065498-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065498-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065498-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2011-05-238072bd15b7f6…

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 UTC2026-02A065498-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065498-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065498-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065498-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065498-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065498-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065498-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065498-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065498-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065498-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065498-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065498-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065498-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065498-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065498-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065498-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065498-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065498-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065498-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065498-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065498-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065498-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065498-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065498-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065498-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065498-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065498-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065498-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065498-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065498-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065498-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065498-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065498-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065498-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065498-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065498-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065498-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065498-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065498-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065498-001AP18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-166-48EA - Each25021-166bbab4a48-ea02-4a13-83f0-c45bc902575712012-07-24

DailyMed Socrata Ingredients#

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 SODIUM AND TAZOBACTAM SODIUMEugia US LLC39e19789-de4b-4fd1-ab1c-92f59496f4962025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065498
application number: ANDA065498
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLCa5d8625e-e630-4076-bc55-46ebe861c6a52025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065498
application number: ANDA065498

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-166-482502101664810 VIAL in 1 CARTON (25021-166-48) > 20 mL in 1 VIAL10 vial2011-06-162022-12-31NoNoCurrent