Pantoprazole Sodium Tablet, Delayed Release
NDC Package 35573-428-80

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

Package Information

Pantoprazole Sodium 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 Burel Pharmaceuticals, Llc, this product is identified by NDC 35573-428 and is authorized under FDA application ANDA202038.

Identification & Billing

NDC Package Code
35573-428-80
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Product Code
35573-428
11-Digit Billing Format
35573042880
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
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 Sodium
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
Burel Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202038
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-20-2020
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 35573-428-80 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet, delayed release in 1 blister pack of Pantoprazole Sodium, a human prescription drug labeled by Burel Pharmaceuticals, Llc. 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 Burel Pharmaceuticals, Llc on April 20, 2020. The current certification is valid through December 31, 2027.

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 Burel Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35573042880. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. 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)
35573-428-80
11-Digit CMS (5-4-2)
35573-0428-80

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