Amrix Capsule, Extended Release
NDC Package 63459-700-22

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

Amrix (cyclobenzaprine hydrochloride) capsules is cyclobenzaprine is used short-term to treat muscle spasms. This formulation utilizes a capsule, extended release delivery system. Marketed by Cephalon, Llc, this product is identified by NDC 63459-700 and is authorized under FDA application NDA021777.

Identification & Billing

NDC Package Code
63459-700-22
Package Description
5 BLISTER PACK in 1 CARTON / 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (63459-700-02)
Product Code
63459-700
11-Digit Billing Format
63459070022
RxNorm Crosswalk
  • RxCUI: 828353 - cyclobenzaprine HCl 30 MG 24HR Extended Release Oral Capsule
  • RxCUI: 828353 - 24 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule
  • RxCUI: 828353 - cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 828355 - Amrix 30 MG 24HR Extended Release Oral Capsule
  • RxCUI: 828355 - 24 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule [Amrix]

Clinical Specifications

Proprietary Name
Amrix
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 is used short-term to treat muscle spasms. It is usually used along with rest and physical therapy. It works by helping to relax the muscles. This medication is not recommended for use in older adults because they may be at greater risk for side effects while using this drug. Ask the doctor or pharmacist for details.

Regulatory & Marketing

Labeler Name
Cephalon, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021777
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-02-2007
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63459-700). Click a package code to view its specific billing and regulatory data.

63459-700-15
10 BLISTER PACK in 1 CARTON / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (63459-700-11)
63459-700-60
60 CAPSULE, EXTENDED RELEASE 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 63459-700-22 identifies a specific commercial package of 5 blister pack in 1 carton / 2 capsule, extended release in 1 blister pack (63459-700-02) of Amrix, a human prescription drug labeled by Cephalon, Llc. 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 Cephalon, Llc on October 02, 2007. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cyclobenzaprine is used short-term to treat muscle spasms. It is usually used along with rest and physical therapy. It works by helping to relax the muscles. This medication is not recommended for use in older adults because they may be at greater risk for side effects while using this drug. Ask the doctor or pharmacist for details.

How is this Cephalon, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63459070022. 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)
63459-700-22
11-Digit CMS (5-4-2)
63459-0700-22

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