Piperacillin and Tazobactam

Product NDC
61990-0150
Requested package NDC
61990-0150-1
11-digit product format
619900150
Labeler code
61990
Product ID
61990-0150_65c48c5c-d59e-179f-3178-765d632d192f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin sodium and Tazobactam sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apollo Pharmaceuticals Inc.
Application
ANDA207848
Marketing category
ANDA
Marketing start
2019-08-01
Marketing end
0000-00-00
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36 g/180mL; g/180mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage61990-015061990-0150-1DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207848-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11
A207848-002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207848-001AP
A207848-002AP

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207848-001PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP2018-05-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A207848-002PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-01-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207848-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207848-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207848-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207848-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207848-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207848-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207848-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207848-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207848-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207848-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207848-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207848-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207848-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207848-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207848-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207848-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207848-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207848-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207848-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207848-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207848-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207848-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207848-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207848-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207848-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207848-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207848-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207848-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207848-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207848-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207848-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207848-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207848-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207848-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207848-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207848-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207848-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207848-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207848-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207848-002AP1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61990-0150-1EA - Each61990-0150b41da892-b325-4011-90ea-89f9b2599af312019-08-06

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMProvepharm Inc.68d5384d-1691-4afc-8a1a-488f8e2ef2c52025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207848
application number: ANDA207848

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61990-0150-1619900150011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (61990-0150-1) > 180 mL in 1 VIAL, PHARMACY BULK PACKAGE2019-08-010000-00-00NoNoCurrent