Cyclobenzaprine Hydrochloride Capsule, Extended Release
NDC Package 72189-101-60

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

Package Information

Cyclobenzaprine Hydrochloride capsules is cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. This formulation utilizes a capsule, extended release delivery system. Marketed by Direct Rx, this product is identified by NDC 72189-101 and is authorized under FDA application ANDA091281.

Identification & Billing

NDC Package Code
72189-101-60
Package Description
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
72189-101
11-Digit Billing Format
72189010160
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 828358 - cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule
  • RxCUI: 828358 - 24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule
  • RxCUI: 828358 - cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Cyclobenzaprine Hydrochloride
Non-Proprietary Name
Cyclobenzaprine Hydrochloride
Substance Name
Cyclobenzaprine Hydrochloride
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)
CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1
Pharmacologic Class
Usage Information
Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion.Limitations of Use:Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.

Regulatory & Marketing

Labeler Name
Direct Rx
Product Type
Human Prescription Drug
FDA Application #
ANDA091281
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-07-2020
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 72189-101-60 identifies a specific commercial package of 60 capsule, extended release in 1 bottle of Cyclobenzaprine Hydrochloride, a human prescription drug labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This capsule, extended release is formulated for oral use and contains cyclobenzaprine 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 Direct Rx on May 07, 2020. The current certification is valid through December 31, 2026.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189010160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
72189-101-60
11-Digit CMS (5-4-2)
72189-0101-60

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