Pantoprazole Sodium Tablet, Delayed Release
NDC Package 68071-4864-9

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

Package Information

Pantoprazole Sodium (pantoprazole) tablets is pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). This formulation utilizes a tablet, delayed release delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-4864 and is authorized under FDA application ANDA202882.

Identification & Billing

NDC Package Code
68071-4864-9
Package Description
90 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
68071-4864
11-Digit Billing Format
68071486409
RxNorm Crosswalk
  • RxCUI: 314200 - pantoprazole sodium 40 MG Delayed Release Oral Tablet
  • RxCUI: 314200 - pantoprazole 40 MG Delayed Release Oral Tablet
  • RxCUI: 314200 - pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Pantoprazole Sodium
Non-Proprietary Name
Pantoprazole
Substance Name
Pantoprazole Sodium
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PANTOPRAZOLE SODIUM 40 mg/1
Pharmacologic Class
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
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202882
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-10-2014
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 68071-4864-9 identifies a specific commercial package of 90 tablet, delayed release in 1 bottle of Pantoprazole Sodium, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This tablet, delayed release is formulated for oral use and contains pantoprazole 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 Nucare Pharmaceuticals,inc. on September 10, 2014. The current certification is valid through December 31, 2026.

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 Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071486409. 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)
68071-4864-9
11-Digit CMS (5-4-2)
68071-4864-09

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