Cefpodoxime Proxetil Powder
NDC Package 63785-112-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Cefpodoxime Proxetil powders is a medication used to treat a wide variety of bacterial infections. This formulation utilizes a powder delivery system. Marketed by Orchid Pharma Ltd, this product is identified by NDC 63785-112.

Identification & Billing

NDC Package Code
63785-112-01
Package Description
1 BAG in 1 DRUM / 10 kg in 1 BAG
Product Code
63785-112
11-Digit Billing Format
63785011201

Clinical Specifications

Proprietary Name
Cefpodoxime Proxetil
Non-Proprietary Name
Cefpodoxime Proxetil
Substance Name
Cefpodoxime Proxetil
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
CEFPODOXIME PROXETIL 1 kg/kg
Usage Information
This medication is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Orchid Pharma Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-15-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63785-112). Click a package code to view its specific billing and regulatory data.

63785-112-02
3 BAG in 1 DRUM / .05 kg in 1 BAG

* 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 63785-112-01 identifies a specific commercial package of 1 bag in 1 drum / 10 kg in 1 bag of Cefpodoxime Proxetil (UNFINISHED drug), a bulk ingredient labeled by Orchid Pharma Ltd. This powder is formulated for use and contains cefpodoxime proxetil 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 Orchid Pharma Ltd on July 15, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Orchid Pharma Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63785011201. 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)
63785-112-01
11-Digit CMS (5-4-2)
63785-0112-01

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