FDA.reportPublic FDA data

Zosyn

Product NDC
0206-8862
11-digit product format
002068862
Labeler code
0206
Product ID
0206-8862_30496b61-307a-43af-8369-971593382a70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TAZOBACTAM SODIUM and PIPERACILLIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA050750
Marketing category
NDA
Marketing start
1998-03-01
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
4; 500 g/100mL; mg/100mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Zosyn
Brand name suffix
in Galaxy Containers
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM4 g/100mL
TAZOBACTAM SODIUM500 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM98T69Q7HP, UXA545ABTT
Rxcui1659131, 1659134, 1659137, 1659139, 1659149, 1659151

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0206-8862-022024-01-30C16284748780-11030e365-1c1d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN. ZOSYN ® (piperacillin and tazobactam) injection, for intravenous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0206-8862-01Zosynin Galaxy Containers100 mL in 1 BAGINJECTION, SOLUTION1001
0206-8862-02Zosynin Galaxy Containers12 in 1 BOXINJECTION, SOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0206-8862-01ML - Milliliter0206-886254fcc24b-15d2-460b-be2c-6efe300f426212012-07-24
0206-8862-02ML - Milliliter0206-8862d68036de-8991-4eb5-847e-98275d11d94312012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0206-8862ZOSYN IN GALAXY CONTAINERS (TAZOBACTAM SODIUM AND PIPERACILLIN SODIUM) INJECTION, SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]1Current NDC, Legacy NDC, 2 package rows20230324_8ab9d90d-2f7f-4599-a44f-3d0a8f8ab623.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSN8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659137piperacillin / tazobactam 3.375 GM InjectionPSN8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659149piperacillin / tazobactam 4.5 GM InjectionPSN8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659134Zosyn 2.25 GM InjectionPSN8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659139Zosyn 3.375 GM InjectionPSN8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659151Zosyn 4.5 GM InjectionPSN8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659134piperacillin 2000 MG / tazobactam 250 MG Injection [Zosyn]SBD8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659139piperacillin 3000 MG / tazobactam 375 MG Injection [Zosyn]SBD8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659151piperacillin 4000 MG / tazobactam 500 MG Injection [Zosyn]SBD8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659131piperacillin / tazobactam 2.25 GM InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659137piperacillin / tazobactam 3.375 GM InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659149piperacillin / tazobactam 4.5 GM InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659134Zosyn (piperacillin / tazobactam) 2.25 GM InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659139Zosyn (piperacillin / tazobactam) 3.375 GM InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231
1659151Zosyn (piperacillin / tazobactam) 4.5 GM InjectionSY8ab9d90d-2f7f-4599-a44f-3d0a8f8ab6231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0206-8862-0100206886201100 mL in 1 BAG100 mlHistorical
0206-8862-020020688620212 BAG in 1 BOX (0206-8862-02) / 100 mL in 1 BAG (0206-8862-01) 12 bag1998-03-010000-00-00NoNoCurrent