Pantoprazole Sodium
NDC Package 48433-310-10

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Pantoprazole Sodium is pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). Marketed by Safecor Health, Llc, this product is identified by NDC 48433-310 and is authorized under FDA application ANDA202038.

Identification & Billing

NDC Package Code
48433-310-10
Package Description
100 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET, DELAYED RELEASE in 1 POUCH (48433-310-01)
Product Code
48433-310
11-Digit Billing Format
48433031010

Clinical Specifications

Proprietary Name
Pantoprazole Sodium
Dosage Form
-
Usage Information
Pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Pantoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

Regulatory & Marketing

Labeler Name
Safecor Health, Llc
FDA Application #
ANDA202038
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2014
End Marketing Date
10-18-2018
Listing Expiration
10-18-2018
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (48433-310). Click a package code to view its specific billing and regulatory data.

48433-310-75
75 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET, DELAYED RELEASE in 1 POUCH (48433-310-01)

* 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 48433-310-10 identifies a specific commercial package of 100 pouch in 1 box, unit-dose / 1 tablet, delayed release in 1 pouch (48433-310-01) of Pantoprazole Sodium, labeled by Safecor Health, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Safecor Health, Llc on September 30, 2014. The current certification is valid through October 18, 2018.

What are the primary indications for this medication?

Pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Pantoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

How is this Safecor Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48433031010. 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)
48433-310-10
11-Digit CMS (5-4-2)
48433-0310-10

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