Cyclobenzaprine Hydrochloride Tablet, Film Coated
NDC Package 72189-080-10
Package Information
Cyclobenzaprine Hydrochloride tablets is uSP 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, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 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 tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. This formulation utilizes a tablet, film coated delivery system. Marketed by Direct Rx, this product is identified by NDC 72189-080 and is authorized under FDA application ANDA208170.
Identification & Billing
- RxCUI: 828348 - cyclobenzaprine HCl 10 MG Oral Tablet
- RxCUI: 828348 - cyclobenzaprine hydrochloride 10 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 72189 - Direct Rx
- 72189-080 - Cyclobenzaprine Hydrochloride
- 72189-080-10 - 10 TABLET, FILM COATED in 1 BOTTLE
- 72189-080 - Cyclobenzaprine Hydrochloride
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 (72189-080). Click a package code to view its specific billing and regulatory data.
* 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 72189-080-10 identifies a specific commercial package of 10 tablet, film coated 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 10 billable units per package. This tablet, film coated 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 13, 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: 72189008010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
