Dipentum Capsule, Gelatin Coated
NDC Package 0037-6860-10

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

Package Information

Dipentum (olsalazine sodium) capsules is olsalazine is used to treat a certain type of bowel disease called ulcerative colitis. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 0037-6860 and is authorized under FDA application NDA019715.

Identification & Billing

NDC Package Code
0037-6860-10
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC
Product Code
0037-6860
11-Digit Billing Format
00037686010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dipentum
Non-Proprietary Name
Olsalazine Sodium
Substance Name
Olsalazine Sodium
Dosage Form
Capsule, Gelatin Coated - 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; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OLSALAZINE SODIUM 250 mg/1
Pharmacologic Class
Usage Information
Olsalazine is used to treat a certain type of bowel disease called ulcerative colitis. It does not cure ulcerative colitis, but it may decrease symptoms such as stomach pain, diarrhea, and rectal bleeding caused by irritation/swelling of the colon/rectum. After an attack is treated, olsalazine is used to increase the amount of time between attacks. Olsalazine is a salicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural substances (e.g., prostaglandins) that may cause pain and swelling.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019715
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-15-2015
Listing Expiration
12-31-2027
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 0037-6860-10 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle, plastic of Dipentum, a human prescription drug labeled by Viatris Specialty Llc. This capsule, gelatin coated is formulated for oral use and contains olsalazine sodium 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 May 15, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Olsalazine is used to treat a certain type of bowel disease called ulcerative colitis. It does not cure ulcerative colitis, but it may decrease symptoms such as stomach pain, diarrhea, and rectal bleeding caused by irritation/swelling of the colon/rectum. After an attack is treated, olsalazine is used to increase the amount of time between attacks. Olsalazine is a salicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural substances (e.g., prostaglandins) 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: 00037686010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0037-6860-10
11-Digit CMS (5-4-2)
00037-6860-10

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