Zosyn

Product NDC
0338-9636
11-digit product format
003389636
Labeler code
0338
Product ID
0338-9636_d44ebbea-a212-4060-a50b-e7fab8e70ff6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piperacillin sodium and tazobactam sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA050750
Marketing category
NDA
Marketing start
2023-04-01
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
3; .375 g/50mL; g/50mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050750-001ZOSYN IN PLASTIC CONTAINERPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24
N050750-002ZOSYN IN PLASTIC CONTAINERPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24
N050750-003ZOSYN IN PLASTIC CONTAINERPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-24

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-2484e616aacf4f…
2026-09-14 22:38:342026-08N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-2484e616aacf4f…
2026-09-14 22:38:342026-08N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-2484e616aacf4f…
2026-08-18 06:07:402026-07N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050750-002ZOSYN IN PLASTIC CONTAINEREQ 60MG BASE/ML;EQ 7.5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050750-003ZOSYN IN PLASTIC CONTAINEREQ 4GM BASE/100ML;EQ 500MG BASE/100MLINJECTABLE / INJECTIONRLD, RS1998-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050750-001ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/MLINJECTABLE / INJECTIONRLD, RS1998-02-24301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 6 · 228 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00169001842023-04-14U-282Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00179152292023-04-14Drug product2011-04-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00181338832023-04-14U-282Drug product2012-04-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00269001842023-04-14U-282Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00279152292023-04-14Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00281338832023-04-14U-282Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00369001842023-04-14U-282Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00379152292023-04-14Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050750-00381338832023-04-14U-282Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050750-00169001842023-04-14U-282Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050750-00179152292023-04-14Drug product2011-04-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050750-00181338832023-04-14U-282Drug product2012-04-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050750-00269001842023-04-14U-282Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050750-00279152292023-04-14Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050750-00281338832023-04-14U-282Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050750-00369001842023-04-14U-282Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050750-00379152292023-04-14Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050750-00381338832023-04-14U-282Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050750-00169001842023-04-14U-282Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050750-00179152292023-04-14Drug product2011-04-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050750-00181338832023-04-14U-282Drug product2012-04-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050750-00269001842023-04-14U-282Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050750-00279152292023-04-14Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050750-00281338832023-04-14U-282Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050750-00369001842023-04-14U-282Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050750-00379152292023-04-14Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050750-00381338832023-04-14U-282Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050750-00162076612019-02-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00169001842023-04-14U-282Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00179152292023-04-14Drug product2011-04-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00181338832023-04-14U-282Drug product2012-04-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00262076612019-02-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00269001842023-04-14U-282Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00279152292023-04-14Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00281338832023-04-14U-282Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00362076612019-02-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00369001842023-04-14U-282Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00379152292023-04-14Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050750-00381338832023-04-14U-282Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050750-00169001842023-04-14U-282Drug productbb7c543d1eb4…

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
Zosyn
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM3 g/50mL
TAZOBACTAM SODIUM.375 g/50mL

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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659131Internal RxNorm lookup
1659134Internal RxNorm lookup
1659137Internal RxNorm lookup
1659139Internal RxNorm lookup
1659149Internal RxNorm lookup
1659151Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8db6bd91-2106-4bfd-8cc8-38aaf1e18d17Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5fa255cf-091e-4504-8ebf-eef4259776e8Product name120260112
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
a6bfe911-d09e-4049-bcde-a3213184a72cProduct name820240501
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
61877847-a958-4874-a7cf-2bbeff51a37bProduct name220180717
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
e0d9b1cf-1fe5-42a8-b30f-70b3a7bd8d22Product name120150316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9636-01Zosyn50 mL in 1 BAGINJECTION, SOLUTION506
0338-9636-24Zosyn24 in 1 CARTONINJECTION, SOLUTION246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9636-01ML - Milliliter0338-96362cb2857f-9567-431d-9d83-a62294fc7fbc12023-05-05
0338-9636-24ML - Milliliter0338-9636598dbf5a-6f28-4dd5-bc5f-cb0e60c6c93a12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9636ZOSYN (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5Current NDC, 2 package rows20241211_8db6bd91-2106-4bfd-8cc8-38aaf1e18d17.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
ZosynPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMBaxter Healthcare Corporation8db6bd91-2106-4bfd-8cc8-38aaf1e18d172026-05-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 050750
application number: NDA050750
ndc (product): 0338-9636
Zosyn in Galaxy ContainersTAZOBACTAM SODIUM AND PIPERACILLIN SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6232023-03-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 050750
application number: NDA050750

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-9636-010033896360150 mL in 1 BAG50 mlHistorical
0338-9636-240033896362424 BAG in 1 CARTON (0338-9636-24) / 50 mL in 1 BAG (0338-9636-01) 24 bag2023-04-01NoNoCurrent