Ropinirole Hydrochloride
NDC Package 64220-421-01

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.

Ropinirole Hydrochloride is tablets are contraindicated for patients known to have hypersensitivity to the product. Marketed by Zhejiang Huahai Pharmaceutical Co., Ltd., this product is identified by NDC 64220-421 and is authorized under FDA application ANDA078110.

Identification & Billing

NDC Package Code
64220-421-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
64220-421
11-Digit Billing Format
64220042101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ropinirole Hydrochloride
Dosage Form
-
Usage Information
Ropinirole hydrochloride tablets are contraindicated for patients known to have hypersensitivity to the product.

Regulatory & Marketing

Labeler Name
Zhejiang Huahai Pharmaceutical Co., Ltd.
FDA Application #
ANDA078110
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-10-2011
Listing Expiration
12-31-2017
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 (64220-421). Click a package code to view its specific billing and regulatory data.

64220-421-02
500 TABLET, FILM COATED 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 64220-421-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Ropinirole Hydrochloride, labeled by Zhejiang Huahai Pharmaceutical Co., Ltd.. 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 Zhejiang Huahai Pharmaceutical Co., Ltd. on August 10, 2011. The current certification is valid through December 31, 2017.

How is this Zhejiang Huahai Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64220042101. 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)
64220-421-01
11-Digit CMS (5-4-2)
64220-0421-01

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