piperacillin and tazobactam (35369-0501)

Drug Facts

Product Profile

Brand Name piperacillin and tazobactam

Generic Name piperacillin and tazobactam

Labeler shandong anxin pharmaceutical co., ltd.

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

piperacillin sodium 4 g/20mL, tazobactam sodium .5 g/20mL

Manufacturer

Shandong Anxin Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 35369-0501

Product ID 35369-0501_83e081fa-7103-403a-b275-7d7205835a91

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204959

Listing Expiration 2026-12-31

Marketing Start 2018-08-10

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 353690501

Hyphenated Format 35369-0501

Supplemental Identifiers

RxCUI

1659131 1659137 1659149

UPC

0335369050114 0335369050329 0335369050220 0335369050213 0335369050312 0335369050121

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 piperacillin and tazobactam (source: ndc)

Generic Name piperacillin and tazobactam (source: ndc)

Application Number ANDA204959 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

4 g/20mL
.5 g/20mL

source: ndc

Packaging

10 VIAL, SINGLE-DOSE in 1 CARTON (35369-0501-2) / 20 mL in 1 VIAL, SINGLE-DOSE (35369-0501-1)

source: ndc

Packages (1)

35369-0501-2 10 VIAL, SINGLE-DOSE in 1 CARTON (35369-0501-2) / 20 mL in 1 VIAL, SINGLE-DOSE (35369-0501-1)

Ingredients (2)

piperacillin sodium (4 g/20mL) tazobactam sodium (.5 g/20mL)

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": "83e081fa-7103-403a-b275-7d7205835a91", "openfda": {"upc": ["0335369050114", "0335369050329", "0335369050220", "0335369050213", "0335369050312", "0335369050121"], "unii": ["UXA545ABTT", "M98T69Q7HP"], "rxcui": ["1659131", "1659137", "1659149"], "spl_set_id": ["420196a5-f62d-473f-84d8-d7fc3f31c3d3"], "manufacturer_name": ["Shandong Anxin Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (35369-0501-2)  / 20 mL in 1 VIAL, SINGLE-DOSE (35369-0501-1)", "package_ndc": "35369-0501-2", "marketing_start_date": "20180810"}], "brand_name": "Piperacillin and Tazobactam", "product_id": "35369-0501_83e081fa-7103-403a-b275-7d7205835a91", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "35369-0501", "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": "4 g/20mL"}, {"name": "TAZOBACTAM SODIUM", "strength": ".5 g/20mL"}], "application_number": "ANDA204959", "marketing_category": "ANDA", "marketing_start_date": "20180810", "listing_expiration_date": "20261231"}