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  5. NDC Package Code: 0781-5854-31 Pramipexole Dihydrochloride

NDC Package 0781-5854-31 Pramipexole Dihydrochloride

View Billable Units, 11-Digit Format, RxNorm

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.

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:
0781-5854-31
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0781-5854
Proprietary Name:
Pramipexole Dihydrochloride
Usage Information:
Pramipexole is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome"). This medication is also used to treat a certain medical condition (restless legs syndrome - RLS) that causes an unusual urge to move the legs. Symptoms usually occur at night along with uncomfortable/unpleasant feelings in the legs. This medication can decrease these symptoms and thereby improve sleep. Pramipexole is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.
11-Digit NDC Billing Format:
00781585431
Labeler Name:
Sandoz Inc
Sample Package:
No
FDA Application Number:
ANDA202353
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-15-2020
End Marketing Date:
09-15-2020
Listing Expiration Date:
09-15-2020
Exclude Flag:
D
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 0781-5854-31?

The NDC Packaged Code 0781-5854-31 is assigned to a package of 30 tablet, extended release in 1 bottle of Pramipexole Dihydrochloride, labeled by Sandoz Inc. The product's dosage form is and is administered via form.

Is NDC 0781-5854 included in the NDC Directory?

No, Pramipexole Dihydrochloride with product code 0781-5854 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Sandoz Inc on September 15, 2020 and its listing in the NDC Directory is set to expire on September 15, 2020 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0781-5854-31?

The 11-digit format is 00781585431. 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 4-4-2 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
4-4-20781-5854-315-4-200781-5854-31