NDC Package 0037-0066-03 Rowasa

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

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:
0037-0066-03
Package Description:
28 BOTTLE, DISPENSING in 1 CARTON / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)
Product Code:
Proprietary Name:
Rowasa
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:
00037006603
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
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):
    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
    0037-0066-057 BOTTLE, DISPENSING in 1 CARTON / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0037-0066-03?

    The NDC Packaged Code 0037-0066-03 is assigned to a package of 28 bottle, dispensing in 1 carton / 60 ml in 1 bottle, dispensing (0037-0066-06) of Rowasa, a human prescription drug labeled by Meda Pharmaceuticals Inc.. The product's dosage form is suspension and is administered via rectal form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0037-0066 included in the NDC Directory?

    Yes, Rowasa with product code 0037-0066 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 0037-0066-03?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0037-0066-03?

    The 11-digit format is 00037006603. 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
    4-4-20037-0066-035-4-200037-0066-03