NDC 0037-0022-28 Sfrowasa Sulfite-free Formulation

Mesalamine

NDC Package Code 0037-0022-28

The NDC Code 0037-0022-28 is assigned to a package of 28 bottle, with applicator in 1 carton > 60 ml in 1 bottle, with applicator (0037-0022-60) of Sfrowasa Sulfite-free Formulation, a human prescription drug labeled by Meda Pharmaceuticals. The product's dosage form is suspension and is administered via rectal form.

Field Name Field Value
NDC Code 0037-0022-28
Package Description 28 BOTTLE, WITH APPLICATOR in 1 CARTON > 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
Proprietary Name Sfrowasa Sulfite-free Formulation 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.
Non-Proprietary Name Mesalamine 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.
Drug Uses 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.
11-Digit NDC Billing Format 00037002228 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Human Prescription Drug 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.
Labeler Name Meda Pharmaceuticals
Dosage Form Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s)
  • Rectal - Administration to the rectum.
Active Ingredient(s)
  • MESALAMINE 4 g/60mL
Pharmacological Class(es)
  • Aminosalicylate - [EPC] (Established Pharmacologic Class)
  • Aminosalicylic Acids - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number NDA019618 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.
Start Marketing Date 03-29-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
Exclude Flag N 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".

NDC Code Structure

  • 0037 - Meda Pharmaceuticals
    • 0037-0022 - Sfrowasa
      • 0037-0022-28 - 28 BOTTLE, WITH APPLICATOR in 1 CARTON

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 Sfrowasa with product NDC 0037-0022.

NDC Package CodePackage Description
0037-0022-077 BOTTLE, WITH APPLICATOR in 1 CARTON > 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

* Please review the disclaimer below.