Piperacillin And Tazobactam Injection, Powder, Lyophilized, For Solution
NDC Package 71357-023-01

11-digit billing NDC: 71357002301
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Piperacillin And Tazobactam injection is the usual total daily dosage of Piperacillin and tazobactam for injection for adult patients with indications other than nosocomial pneumonia is 3.375 g every six hours [totaling 13.5 g (12.0 g piperacillin and 1.5 g tazobactam], to be administered by intravenous infusion over 30 minutes. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Milla Pharmaceuticals Inc., this product is identified by NDC 71357-023 and is authorized under FDA application ANDA207848.

Identification & Billing

NDC Package Code
71357-023-01
Package Description
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 60 mL in 1 VIAL, PHARMACY BULK PACKAGE
Product Code
71357-023
11-Digit Billing Format
71357002301

Clinical Specifications

Proprietary Name
Piperacillin And Tazobactam
Non-Proprietary Name
Piperacillin And Tazobactam
Substance Name
Piperacillin Sodium; Tazobactam Sodium
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
The usual total daily dosage of Piperacillin and tazobactam for injection for adult patients with indications other than nosocomial pneumonia is 3.375 g every six hours [totaling 13.5 g (12.0 g piperacillin and 1.5 g tazobactam], to be administered by intravenous infusion over 30 minutes. The usual duration of Piperacillin and tazobactam for injection treatment is from 7 to 10 days.

Regulatory & Marketing

Labeler Name
Milla Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207848
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2019
Listing Expiration
12-31-2027
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 71357-023-01 identifies a specific commercial package of 1 vial, pharmacy bulk package in 1 carton / 60 ml in 1 vial, pharmacy bulk package of Piperacillin And Tazobactam, a human prescription drug labeled by Milla Pharmaceuticals Inc.. This injection, powder, lyophilized, 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 Milla Pharmaceuticals Inc. on August 01, 2019. The current certification is valid through December 31, 2027.

How is this Milla Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71357002301. 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 (5-3-2)
71357-023-01
11-Digit CMS (5-4-2)
71357-0023-01

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