Sfrowasa Suspension
NDC Package 0037-0022-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Sfrowasa (mesalamine) suspension is mesalamine (also known as 5-aminosalicylic acid) is used to treat certain types of bowel disease (distal ulcerative colitis, proctosigmoiditis, proctitis). This formulation utilizes a suspension delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 0037-0022 and is authorized under FDA application NDA019618.

Identification & Billing

NDC Package Code
0037-0022-07
Package Description
7 BOTTLE, WITH APPLICATOR in 1 CARTON / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
Product Code
0037-0022
11-Digit Billing Format
00037002207
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sfrowasa Sulfite-free Formulation
Non-Proprietary Name
Mesalamine
Substance Name
Mesalamine
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
MESALAMINE 4 g/60mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019618
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-24-2016
End Marketing Date
07-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0037-0022). Click a package code to view its specific billing and regulatory data.

0037-0022-28
28 BOTTLE, WITH APPLICATOR in 1 CARTON / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0037-0022-07 identifies a specific commercial package of 7 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 Viatris Specialty Llc. This suspension is formulated for rectal use and contains mesalamine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Viatris Specialty Llc on March 24, 2016.

What are the primary indications for this medication?

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.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00037002207. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0037-0022-07
11-Digit CMS (5-4-2)
00037-0022-07

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.