Ropinirole Tablet, Film Coated
NDC Package 46708-034-31

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 parkinson’s DiseaseRopinirole Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.The effectiveness of Ropinirole Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).Restless Legs SyndromeRopinirole Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. This formulation utilizes a tablet, film coated delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-034 and is authorized under FDA application ANDA090429.

Identification & Billing

NDC Package Code
46708-034-31
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
46708-034
11-Digit Billing Format
46708003431
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ropinirole
Non-Proprietary Name
Ropinirole
Substance Name
Ropinirole Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ROPINIROLE HYDROCHLORIDE 3 mg/1
Pharmacologic Class
Usage Information
Parkinson’s DiseaseRopinirole Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.The effectiveness of Ropinirole Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).Restless Legs SyndromeRopinirole Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090429
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-12-2013
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 46708-034-31 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Ropinirole, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This tablet, film coated 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 Alembic Pharmaceuticals Limited on September 12, 2013. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708003431. 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)
46708-034-31
11-Digit CMS (5-4-2)
46708-0034-31

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