Dicyclomine Hydrochloride
NDC Package 68071-3522-3

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dicyclomine Hydrochloride is capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Marketed by Nucare Pharmaceutials,inc., this product is identified by NDC 68071-3522 and is authorized under FDA application ANDA217054.

Identification & Billing

NDC Package Code
68071-3522-3
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
68071-3522
11-Digit Billing Format
68071352203
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dicyclomine Hydrochloride
Dosage Form
-
Usage Information
Dicyclomine hydrochloride capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceutials,inc.
FDA Application #
ANDA217054
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2023
Listing Expiration
12-31-2024
Exclude Flag
I
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 68071-3522-3 identifies a specific commercial package of 30 capsule in 1 bottle of Dicyclomine Hydrochloride, labeled by Nucare Pharmaceutials,inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nucare Pharmaceutials,inc. on February 01, 2023. The current certification is valid through December 31, 2024.

How is this Nucare Pharmaceutials,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071352203. 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 (5-4-1)
68071-3522-3
11-Digit CMS (5-4-2)
68071-3522-03

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