Piperacillin And Tazobactam Injection, Powder, For Solution
NDC Package 35369-0502-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Piperacillin And Tazobactam injection is piperacillin and Tazobactam for Injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Shandong Anxin Pharmaceutical Co., Ltd., this product is identified by NDC 35369-0502 and is authorized under FDA application ANDA204959.

Identification & Billing

NDC Package Code
35369-0502-2
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (35369-0502-1)
Product Code
35369-0502
11-Digit Billing Format
35369050202
RxNorm Crosswalk
  • RxCUI: 1659131 - piperacillin / tazobactam 2.25 GM Injection
  • RxCUI: 1659131 - piperacillin 2000 MG / tazobactam 250 MG Injection
  • RxCUI: 1659131 - piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG Injection
  • RxCUI: 1659137 - piperacillin / tazobactam 3.375 GM Injection
  • RxCUI: 1659137 - piperacillin 3000 MG / tazobactam 375 MG Injection

Clinical Specifications

Proprietary Name
Piperacillin And Tazobactam
Non-Proprietary Name
Piperacillin And Tazobactam
Substance Name
Piperacillin Sodium; Tazobactam Sodium
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Piperacillin and Tazobactam for Injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.

Regulatory & Marketing

Labeler Name
Shandong Anxin Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA204959
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-10-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 35369-0502-2 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (35369-0502-1) of Piperacillin And Tazobactam, a human prescription drug labeled by Shandong Anxin Pharmaceutical Co., Ltd.. This injection, powder, for solution is formulated for intravenous use and contains piperacillin sodium; tazobactam sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Shandong Anxin Pharmaceutical Co., Ltd. on August 10, 2018. The current certification is valid through December 31, 2026.

How is this Shandong Anxin Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35369050202. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
35369-0502-2
11-Digit CMS (5-4-2)
35369-0502-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.