Application 065498

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALNoNo
002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALNoNo
003PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALNoNo

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…

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
ndc (product): 55150-120
ndc (product): 55150-121
ndc (product): 55150-119
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
ndc (product): 55150-120
ndc (product): 55150-121
ndc (product): 55150-119

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-164Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-164Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-164Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-164Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-165Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-165Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-165Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-165Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-166Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-166Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-166Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-166Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
55150-119Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-119Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumEugia US LLCANDACurrent
55150-119Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-119Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-119Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-119Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-120Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-120Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumEugia US LLCANDACurrent
55150-120Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-120Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-120Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-120Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-121Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-121Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumEugia US LLCANDACurrent
55150-121Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-121Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-121Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent
55150-121Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumAuroMedics Pharma LLCANDACurrent