Protonix Granule, Delayed Release
NDC Package 0008-0844-02

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

Package Information

Protonix (pantoprazole sodium) granules is pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). This formulation utilizes a granule, delayed release delivery system. Marketed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc., this product is identified by NDC 0008-0844 and is authorized under FDA application NDA022020.

Identification & Billing

NDC Package Code
0008-0844-02
Package Description
30 PACKET in 1 CARTON / 1 GRANULE, DELAYED RELEASE in 1 PACKET (0008-0844-01)
Product Code
0008-0844
11-Digit Billing Format
00008084402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 251872 - pantoprazole sodium 20 MG Delayed Release Oral Tablet
  • RxCUI: 251872 - pantoprazole 20 MG Delayed Release Oral Tablet
  • RxCUI: 251872 - pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet
  • RxCUI: 284400 - Protonix 40 MG Delayed Release Oral Tablet
  • RxCUI: 284400 - pantoprazole 40 MG Delayed Release Oral Tablet [Protonix]

Clinical Specifications

Proprietary Name
Protonix Delayed-release
Non-Proprietary Name
Pantoprazole Sodium
Substance Name
Pantoprazole Sodium
Dosage Form
Granule, Delayed Release - A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines.
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
Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022020
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-29-2008
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 0008-0844-02 identifies a specific commercial package of 30 packet in 1 carton / 1 granule, delayed release in 1 packet (0008-0844-01) of Protonix Delayed-release, a human prescription drug labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. This granule, 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 Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc. on February 29, 2008. 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 Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00008084402. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0008-0844-02
11-Digit CMS (5-4-2)
00008-0844-02

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