Ropinirole Tablet, Film Coated, Extended Release
NDC Package 0228-3640-03

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

Package Information

Ropinirole tablets is ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0228-3640 and is authorized under FDA application ANDA090869.

Identification & Billing

NDC Package Code
0228-3640-03
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
0228-3640
11-Digit Billing Format
00228364003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 799054 - rOPINIRole 8 MG 24HR Extended Release Oral Tablet
  • RxCUI: 799054 - 24 HR ropinirole 8 MG Extended Release Oral Tablet
  • RxCUI: 799054 - ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 799054 - ropinirole 8 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 799055 - rOPINIRole 2 MG 24HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Ropinirole
Non-Proprietary Name
Ropinirole
Substance Name
Ropinirole Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ROPINIROLE HYDROCHLORIDE 6 mg/1
Pharmacologic Class
Usage Information
Ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090869
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-23-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0228-3640-03 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Ropinirole, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet, film coated, extended release is formulated for oral use and contains ropinirole 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 Actavis Pharma, Inc. on August 23, 2012. The current certification is valid through December 31, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00228364003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0228-3640-03
11-Digit CMS (5-4-2)
00228-3640-03

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