1. Home
  2. Labeler Index
  3. Actavis Pharma, Inc.
  4. NDC Product Code: 0591-3138 Nizatidine

NDC 0591-3138 Nizatidine

Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0591-3138?
  5. Nizatidine Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
0591-3138
Proprietary Name:
Nizatidine
Non-Proprietary Name: [1]
Nizatidine
Substance Name: [2]
Nizatidine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Actavis Pharma, Inc.
    Labeler Code:
    0591
    Product Label ID:
    367a1004-59c1-4474-a4f6-ce8bf5a1b043
    FDA Application Number: [6]
    ANDA075616
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    07-09-2002
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - BUFF OPAQUE)
    BROWN (C48332 - LIGHT BROWN OPAQUE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    18 MM
    22 MM
    Imprint(s):
    WPI;3137
    WPI;3138
    Score:
    1

    Product Packages

    NDC Code 0591-3138-00

    Package Description: 19000 CAPSULE in 1 BAG

    NDC Code 0591-3138-30

    Package Description: 30 CAPSULE in 1 BOTTLE, PLASTIC

    Price per Unit: $0.45067 per EA

    Product Details

    What is NDC 0591-3138?

    The NDC code 0591-3138 is assigned by the FDA to the product Nizatidine which is a human prescription drug product labeled by Actavis Pharma, Inc.. The product's dosage form is capsule and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0591-3138-00 19000 capsule in 1 bag , 0591-3138-30 30 capsule in 1 bottle, plastic . 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 Nizatidine?

    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.

    What are Nizatidine 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.
    • NIZATIDINE 300 mg/1 - A histamine H2 receptor antagonist with low toxicity that inhibits gastric acid secretion. The drug is used for the treatment of duodenal ulcers.
    • NIZATIDINE 300 mg/1 - A histamine H2 receptor antagonist with low toxicity that inhibits gastric acid secretion. The drug is used for the treatment of duodenal ulcers.

    Which are Nizatidine UNII Codes?

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

    Which are Nizatidine 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:

    Which are the Pharmacologic Classes for Nizatidine?

    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.

    * Please review the disclaimer below.

    Patient Education

    Nizatidine


    Nizatidine is used to treat and prevent the recurrence of ulcers and to treat other conditions where the stomach makes too much acid. Nizatidine also is used to treat or prevent occasional heartburn, acid indigestion, or sour stomach. It decreases the amount of acid made in the stomach. Nizatidine is available with and without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".