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  5. NDC Package Code: 46708-035-31 Ropinirole

NDC Package 46708-035-31 Ropinirole

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
46708-035-31
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
46708-035
Proprietary Name:
Ropinirole
Non-Proprietary Name:
Ropinirole
Substance Name:
Ropinirole Hydrochloride
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.
11-Digit NDC Billing Format:
46708003531
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Alembic Pharmaceuticals Limited
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
ROPINIROLE HYDROCHLORIDE 4 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA090429
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-12-2013
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 46708-035-31?

The NDC Packaged Code 46708-035-31 is assigned to a package of 100 tablet, film coated in 1 bottle of Ropinirole, a human prescription drug labeled by Alembic Pharmaceuticals Limited. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 46708-035 included in the NDC Directory?

Yes, Ropinirole with product code 46708-035 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Limited on September 12, 2013 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 46708-035-31?

The 11-digit format is 46708003531. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-246708-035-315-4-246708-0035-31