zosyn

Generic: piperacillin sodium and tazobactam sodium

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zosyn
Generic Name piperacillin sodium and tazobactam sodium
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

piperacillin sodium 4 g/100mL, tazobactam sodium .5 g/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-9638
Product ID 0338-9638_d1d6e9c8-a033-4e26-a687-e6325808fa0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050750
Listing Expiration 2026-12-31
Marketing Start 2023-04-01

Pharmacologic Class

Classes
penicillin-class antibacterial [epc] penicillins [cs] beta lactamase inhibitor [epc] beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03389638
Hyphenated Format 0338-9638

Supplemental Identifiers

RxCUI
1659131 1659134 1659137 1659139 1659149 1659151
UNII
UXA545ABTT M98T69Q7HP

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zosyn (source: ndc)
Generic Name piperacillin sodium and tazobactam sodium (source: ndc)
Application Number NDA050750 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 g/100mL
  • .5 g/100mL
source: ndc
Packaging
  • 12 BAG in 1 CARTON (0338-9638-12) / 100 mL in 1 BAG (0338-9638-01)
source: ndc

Packages (1)

0338-9638-12 12 BAG in 1 CARTON (0338-9638-12) / 100 mL in 1 BAG (0338-9638-01)

Ingredients (2)

piperacillin sodium (4 g/100mL) tazobactam sodium (.5 g/100mL)

Linked Drug Pages (1)

Zosyn ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d1d6e9c8-a033-4e26-a687-e6325808fa0a", "openfda": {"unii": ["UXA545ABTT", "M98T69Q7HP"], "rxcui": ["1659131", "1659134", "1659137", "1659139", "1659149", "1659151"], "spl_set_id": ["8db6bd91-2106-4bfd-8cc8-38aaf1e18d17"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CARTON (0338-9638-12)  / 100 mL in 1 BAG (0338-9638-01)", "package_ndc": "0338-9638-12", "marketing_start_date": "20230401"}], "brand_name": "Zosyn", "product_id": "0338-9638_d1d6e9c8-a033-4e26-a687-e6325808fa0a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0338-9638", "generic_name": "piperacillin sodium and tazobactam sodium", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zosyn", "active_ingredients": [{"name": "PIPERACILLIN SODIUM", "strength": "4 g/100mL"}, {"name": "TAZOBACTAM SODIUM", "strength": ".5 g/100mL"}], "application_number": "NDA050750", "marketing_category": "NDA", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}