piperacillin and tazobactam

Generic: piperacillin and tazobactam

Labeler: shandong anxin pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name piperacillin and tazobactam
Generic Name piperacillin and tazobactam
Labeler shandong anxin pharmaceutical co., ltd.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

piperacillin sodium 36 g/180mL, tazobactam sodium 4.5 g/180mL

Manufacturer
Shandong Anxin Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 35369-0504
Product ID 35369-0504_7557a940-1967-4f48-8c56-d494b793d934
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217243
Listing Expiration 2026-12-31
Marketing Start 2023-04-14

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 353690504
Hyphenated Format 35369-0504

Supplemental Identifiers

RxCUI
312447
UPC
0335369050411
UNII
M98T69Q7HP UXA545ABTT

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 piperacillin and tazobactam (source: ndc)
Generic Name piperacillin and tazobactam (source: ndc)
Application Number ANDA217243 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 36 g/180mL
  • 4.5 g/180mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (35369-0504-1) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

35369-0504-1 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (35369-0504-1) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE

Ingredients (2)

piperacillin sodium (36 g/180mL) tazobactam sodium (4.5 g/180mL)

Linked Drug Pages (1)

Piperacillin and Tazobactam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7557a940-1967-4f48-8c56-d494b793d934", "openfda": {"upc": ["0335369050411"], "unii": ["M98T69Q7HP", "UXA545ABTT"], "rxcui": ["312447"], "spl_set_id": ["f817b9be-b12b-48ac-8e4e-57ef6812eb32"], "manufacturer_name": ["Shandong Anxin Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (35369-0504-1)  / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "35369-0504-1", "marketing_start_date": "20230414"}], "brand_name": "Piperacillin and Tazobactam", "product_id": "35369-0504_7557a940-1967-4f48-8c56-d494b793d934", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "35369-0504", "generic_name": "Piperacillin and Tazobactam", "labeler_name": "Shandong Anxin Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Piperacillin and Tazobactam", "active_ingredients": [{"name": "PIPERACILLIN SODIUM", "strength": "36 g/180mL"}, {"name": "TAZOBACTAM SODIUM", "strength": "4.5 g/180mL"}], "application_number": "ANDA217243", "marketing_category": "ANDA", "marketing_start_date": "20230414", "listing_expiration_date": "20261231"}