Cyclobenzaprine Hydrochloride
NDC Package 71085-010-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Cyclobenzaprine Hydrochloride is a . Marketed by Ipg Pharmaceuticals, Inc., this product is identified by NDC 71085-010 and is authorized under FDA application ANDA078722.

Identification & Billing

NDC Package Code
71085-010-01
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
71085-010
11-Digit Billing Format
71085001001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA

Clinical Specifications

Proprietary Name
Cyclobenzaprine Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Ipg Pharmaceuticals, Inc.
FDA Application #
ANDA078722
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2017
End Marketing Date
12-01-2024
Listing Expiration
12-01-2024
Exclude Flag
D
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 71085-010-01 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Cyclobenzaprine Hydrochloride, labeled by Ipg Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1000 billable units per package. 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 Ipg Pharmaceuticals, Inc. on August 01, 2017. The current certification is valid through December 01, 2024.

How is this Ipg Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71085001001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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)
71085-010-01
11-Digit CMS (5-4-2)
71085-0010-01

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