NDC 0008-4001 Protonix I.v.
Pantoprazole Sodium Injection, Powder, For Solution Intravenous

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0008-4001?
    4. Protonix I.v. Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0008-4001
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Protonix I.v.
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Pantoprazole Sodium
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Pantoprazole Sodium
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormInjection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravenous - Administration within or into a vein or veins.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
Labeler Code0008
SPL SET ID:f39b3e7d-39d2-4c8a-9974-4ab885241880
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		NDA020988
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		05-01-2013
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Packages

NDC Code 0008-4001-10

Package Description: 10 CARTON in 1 PACKAGE / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIAL

Price per Unit: $3.79440 per EA

NDC Code 0008-4001-25

Package Description: 25 CARTON in 1 PACKAGE / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIAL

Product Details

What is NDC 0008-4001?

The NDC code 0008-4001 is assigned by the FDA to the product Protonix I.v. which is a human prescription drug product labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The generic name of Protonix I.v. is pantoprazole sodium. The product's dosage form is injection, powder, for solution and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 0008-4001-10 10 carton in 1 package / 1 vial in 1 carton (0008-4001-01) / 10 ml in 1 vial, 0008-4001-25 25 carton in 1 package / 1 vial in 1 carton (0008-4001-01) / 10 ml in 1 vial. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Protonix I.v.?

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).

What are Protonix I.v. Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • PANTOPRAZOLE SODIUM 40 mg/10mL - 2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.

Which are Protonix I.v. UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Protonix I.v. Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Protonix I.v.?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes for Protonix I.v.?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Pantoprazole Injection


Pantoprazole injection is used as a short-term treatment to treat gastroesophageal reflux disease (GERD; a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus [the tube between the throat and stomach]) in people who have had damage to their esophagus and who are unable to take pantoprazole by mouth. It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas and small intestine that caused increased production of stomach acid). Pantoprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
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Product Label

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