NDC 0037-0066 Rowasa

Mesalamine Suspension Rectal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0037-0066
Proprietary Name:
Rowasa
Non-Proprietary Name: [1]
Mesalamine
Substance Name: [2]
Mesalamine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
  • Rectal - Administration to the rectum.
  • Labeler Name: [5]
    Meda Pharmaceuticals Inc.
    Labeler Code:
    0037
    FDA Application Number: [6]
    NDA019618
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-24-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)

    Product Packages

    NDC Code 0037-0066-03

    Package Description: 28 BOTTLE, DISPENSING in 1 CARTON / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)

    NDC Code 0037-0066-05

    Package Description: 7 BOTTLE, DISPENSING in 1 CARTON / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)

    Product Details

    What is NDC 0037-0066?

    The NDC code 0037-0066 is assigned by the FDA to the product Rowasa which is a human prescription drug product labeled by Meda Pharmaceuticals Inc.. The generic name of Rowasa is mesalamine. The product's dosage form is suspension and is administered via rectal form. The product is distributed in 2 packages with assigned NDC codes 0037-0066-03 28 bottle, dispensing in 1 carton / 60 ml in 1 bottle, dispensing (0037-0066-06), 0037-0066-05 7 bottle, dispensing in 1 carton / 60 ml in 1 bottle, dispensing (0037-0066-06). 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 Rowasa?

    Mesalamine (also known as 5-aminosalicylic acid) is used to treat certain types of bowel disease (distal ulcerative colitis, proctosigmoiditis, proctitis). It does not cure these conditions, but it may relieve mild-to-moderate pain and decrease the frequency of diarrhea/bloody stools caused by irritation/swelling in the colon/rectum. Mesalamine is an aminosalicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural chemicals that may cause pain and swelling.

    What are Rowasa 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.
    • MESALAMINE 4 g/60mL - An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)

    Which are Rowasa UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Rowasa?

    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 Rowasa?

    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

    Mesalamine Rectal


    Rectal mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), proctitis (swelling in the rectum), and proctosigmoiditis (swelling in the rectum and sigmoid colon [last section of the colon]). Rectal mesalamine is in a class of medications called anti-inflammatory agents. It works by stopping the body from producing a certain substance that may cause inflammation.
    [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".