Orange Book product · Brand (NDA)
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
At a glance
Apr 03, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 03, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Strength
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 206056
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1998ZOSYN IN PLASTIC CONTAINERBrand (NDA)
NDA 050750 · BAXTER HLTHCARE CORP
- 1993ZOSYNBrand (NDA)
NDA 050684 · WYETH PHARMS
- 2023PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 217409 · EUGIA PHARMA
- 2023PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 217243 · SHANDONG
- 2021PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 208674 · SAGENT PHARMS INC
- 2021PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 208675 · SAGENT PHARMS INC
- 2019PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 212287 · ASTRAL
- 2018PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 204959 · SHANDONG
- 2018PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 203719 · FRESENIUS KABI
- 2018PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 203720 · FRESENIUS KABI
- 2018PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 206204 · FRESENIUS KABI USA
- 2017PIPERACILLIN AND TAZOBACTAMGeneric (ANDA)
ANDA 206996 · APOTEX
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

