1. Home
  2. Labeler Index
  3. Coupler Llc
  4. 67046-1566
  5. NDC Package Code: 67046-1566-3 Cyclobenzaprine Hydrochloride

NDC Package 67046-1566-3 Cyclobenzaprine Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
67046-1566-3
Package Description:
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
67046-1566
Proprietary Name:
Cyclobenzaprine Hydrochloride
Non-Proprietary Name:
Cyclobenzaprine Hydrochloride
Substance Name:
Cyclobenzaprine Hydrochloride
Usage Information:
Cyclobenzaprine hydrochloride tablets, 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.
11-Digit NDC Billing Format:
67046156603
Product Type:
Human Prescription Drug
Labeler Name:
Coupler Llc
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA208170
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-17-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 67046-1566-3?

The NDC Packaged Code 67046-1566-3 is assigned to a package of 30 tablet, film coated in 1 blister pack of Cyclobenzaprine Hydrochloride, a human prescription drug labeled by Coupler Llc. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 67046-1566 included in the NDC Directory?

Yes, Cyclobenzaprine Hydrochloride with product code 67046-1566 is active and included in the NDC Directory. The product was first marketed by Coupler Llc on June 17, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 67046-1566-3?

The 11-digit format is 67046156603. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-167046-1566-35-4-267046-1566-03