Dicyclomine Hydrochloride Capsule
NDC Package 24979-201-01

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

Package Information

Dicyclomine Hydrochloride capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. This formulation utilizes a capsule delivery system. Marketed by Upsher-smith Laboratories, Llc, this product is identified by NDC 24979-201 and is authorized under FDA application ANDA217054.

Identification & Billing

NDC Package Code
24979-201-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
24979-201
11-Digit Billing Format
24979020101
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
Dicyclomine Hydrochloride
Non-Proprietary Name
Dicyclomine Hydrochloride
Substance Name
Dicyclomine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DICYCLOMINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Dicyclomine hydrochloride capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

Regulatory & Marketing

Labeler Name
Upsher-smith Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217054
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2023
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (24979-201). Click a package code to view its specific billing and regulatory data.

24979-201-03
1000 CAPSULE in 1 BOTTLE

* 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 24979-201-01 identifies a specific commercial package of 100 capsule in 1 bottle of Dicyclomine Hydrochloride, a human prescription drug labeled by Upsher-smith Laboratories, Llc. This capsule is formulated for oral use and contains dicyclomine hydrochloride 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 Upsher-smith Laboratories, Llc on February 01, 2023. The current certification is valid through December 31, 2027.

How is this Upsher-smith Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24979020101. 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 (5-3-2)
24979-201-01
11-Digit CMS (5-4-2)
24979-0201-01

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