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  5. NDC Package Code: 0591-3138-00 Nizatidine

NDC Package 0591-3138-00 Nizatidine

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0591-3138-00
Package Description:
19000 CAPSULE in 1 BAG
Product Code:
0591-3138
Proprietary Name:
Nizatidine
Non-Proprietary Name:
Nizatidine
Substance Name:
Nizatidine
Usage Information:
Nizatidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Nizatidine belongs to a class of drugs known as H2 blockers.
11-Digit NDC Billing Format:
00591313800
Product Type:
Human Prescription Drug
Labeler Name:
Actavis Pharma, Inc.
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • NIZATIDINE 300 mg/1
  • NIZATIDINE 300 mg/1
    • Pharmacologic Class(es):
  • Histamine H2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-2 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    N/A
    FDA Application Number:
    ANDA075616
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-09-2002
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0591-3138-3030 CAPSULE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0591-3138-00?

    The NDC Packaged Code 0591-3138-00 is assigned to a package of 19000 capsule in 1 bag of Nizatidine, a human prescription drug labeled by Actavis Pharma, Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 0591-3138 included in the NDC Directory?

    Yes, Nizatidine with product code 0591-3138 is active and included in the NDC Directory. The product was first marketed by Actavis Pharma, Inc. on July 09, 2002 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0591-3138-00?

    The 11-digit format is 00591313800. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20591-3138-005-4-200591-3138-00