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  5. NDC Package Code: 0037-0022-07 Sfrowasa Sulfite-free Formulation

NDC Package 0037-0022-07 Sfrowasa Sulfite-free Formulation

Mesalamine Suspension Rectal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Sfrowasa Sulfite-free Formulation
Non-Proprietary Name:
Mesalamine
Substance Name:
Mesalamine
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.
11-Digit NDC Billing Format:
00037002207
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 206798 - sfRowasa 4 GM per 60 mL Enema
  • RxCUI: 206798 - mesalamine 66.7 MG/ML Enema [Rowasa]
  • RxCUI: 206798 - Rowasa 4 GM per 60 ML Enema
  • RxCUI: 206798 - Rowasa 66.7 MG/ML Enema
  • RxCUI: 206798 - sfRowasa 4 GM per 60 ML Enema
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Meda Pharmaceuticals Inc.
    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
    • Pharmacologic Class(es):
  • Aminosalicylate - [EPC] (Established Pharmacologic Class)
  • Aminosalicylic Acids - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA019618
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-24-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 this product:

    NDC Package CodePackage Description
    0037-0022-2828 BOTTLE, WITH APPLICATOR in 1 CARTON / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0037-0022-07?

    The NDC Packaged Code 0037-0022-07 is assigned to a 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 Meda Pharmaceuticals Inc.. The product's dosage form is suspension and is administered via rectal form.

    Is NDC 0037-0022 included in the NDC Directory?

    Yes, Sfrowasa Sulfite-free Formulation with product code 0037-0022 is active and included in the NDC Directory. The product was first marketed by Meda Pharmaceuticals Inc. on March 24, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0037-0022-07?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0037-0022-07?

    The 11-digit format is 00037002207. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20037-0022-075-4-200037-0022-07