Mesalamine Capsule, Extended Release
NDC Package 68682-113-20

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

Package Information

Mesalamine capsules is a medication used to treat a certain bowel disease (ulcerative colitis). This formulation utilizes a capsule, extended release delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-113 and is authorized under FDA application NDA022301.

Identification & Billing

NDC Package Code
68682-113-20
Package Description
1 BOTTLE in 1 CARTON / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
68682-113
11-Digit Billing Format
68682011320
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 825130 - mesalamine 0.375 GM 24HR Extended Release Oral Capsule
  • RxCUI: 825130 - 24 HR mesalamine 375 MG Extended Release Oral Capsule
  • RxCUI: 825130 - mesalamine 375 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 825130 - mesalazine 375 MG 24 HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Mesalamine
Non-Proprietary Name
Mesalamine
Substance Name
Mesalamine
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MESALAMINE 375 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA022301
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-19-2018
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68682-113-20 identifies a specific commercial package of 1 bottle in 1 carton / 120 capsule, extended release in 1 bottle of Mesalamine, a human prescription drug labeled by Oceanside Pharmaceuticals. This capsule, extended release is formulated for oral 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 Oceanside Pharmaceuticals on July 19, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682011320. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (5-3-2)
68682-113-20
11-Digit CMS (5-4-2)
68682-0113-20

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