Cyclobenzaprine Hydrochloride
NDC Package 67046-148-28

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cyclobenzaprine Hydrochloride is medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Marketed by Coupler Enterprises, this product is identified by NDC 67046-148 and is authorized under FDA application ANDA090478.

Identification & Billing

NDC Package Code
67046-148-28
Package Description
28 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
67046-148
11-Digit Billing Format
67046014828
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyclobenzaprine Hydrochloride
Dosage Form
-
Usage Information
Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.

Regulatory & Marketing

Labeler Name
Coupler Enterprises
FDA Application #
ANDA090478
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-22-2016
Listing Expiration
12-31-2021
Exclude Flag
I
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 (67046-148). Click a package code to view its specific billing and regulatory data.

67046-148-07
7 TABLET, FILM COATED in 1 BLISTER PACK
67046-148-14
14 TABLET, FILM COATED in 1 BLISTER PACK
67046-148-15
15 TABLET, FILM COATED in 1 BLISTER PACK
67046-148-20
20 TABLET, FILM COATED in 1 BLISTER PACK
67046-148-21
21 TABLET, FILM COATED in 1 BLISTER PACK
67046-148-30
30 TABLET, FILM COATED in 1 BLISTER PACK
67046-148-60
60 TABLET, FILM COATED in 1 BLISTER PACK

* 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 67046-148-28 identifies a specific commercial package of 28 tablet, film coated in 1 blister pack of Cyclobenzaprine Hydrochloride, labeled by Coupler Enterprises. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Coupler Enterprises on July 22, 2016. The current certification is valid through December 31, 2021.

How is this Coupler Enterprises product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046014828. 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)
67046-148-28
11-Digit CMS (5-4-2)
67046-0148-28

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