NDC 42291-233 Diclofenac Sodium And Misoprostol

Tablet, Delayed Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
42291-233
Proprietary Name:
Diclofenac Sodium And Misoprostol
Non-Proprietary Name: [1]
Diclofenac Sodium And Misoprostol
Substance Name: [2]
Diclofenac Sodium; Misoprostol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Avkare
    Labeler Code:
    42291
    FDA Application Number: [6]
    ANDA201089
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    12-14-2012
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    11 MM
    Imprint(s):
    0397
    0398
    Score:
    1

    Product Packages

    NDC Code 42291-233-60

    Package Description: 60 TABLET, DELAYED RELEASE in 1 BOTTLE

    Product Details

    What is NDC 42291-233?

    The NDC code 42291-233 is assigned by the FDA to the product Diclofenac Sodium And Misoprostol which is a human prescription drug product labeled by Avkare. The product's dosage form is tablet, delayed release and is administered via oral form. The product is distributed in a single package with assigned NDC code 42291-233-60 60 tablet, delayed release in 1 bottle . 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 Diclofenac Sodium And Misoprostol?

    Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].

    What are Diclofenac Sodium And Misoprostol 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.
    • DICLOFENAC SODIUM 75 mg/1 - A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
    • MISOPROSTOL 200 ug/1 - A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.

    Which are Diclofenac Sodium And Misoprostol UNII Codes?

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

    Which are Diclofenac Sodium And Misoprostol 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 Diclofenac Sodium And Misoprostol?

    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:
    • RxCUI: 1359105 - diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet
    • RxCUI: 1359105 - diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet
    • RxCUI: 1359105 - diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet
    • RxCUI: 1359105 - diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet
    • RxCUI: 857706 - diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet

    Which are the Pharmacologic Classes for Diclofenac Sodium And Misoprostol?

    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

    Diclofenac and Misoprostol


    The combination of diclofenac and misoprostol is used to relieve the pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints) in patients who have a high risk of developing stomach ulcers. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain and inflammation. Misoprostol is in a class of medications called prostaglandins. It prevents ulcers caused by diclofenac by protecting the stomach lining and decreasing stomach acid production.
    [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".