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  5. NDC Package Code: 70771-1328-3 Pramipexole Dihydrochloride

NDC Package 70771-1328-3 Pramipexole Dihydrochloride

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
70771-1328-3
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
70771-1328
Proprietary Name:
Pramipexole Dihydrochloride
Non-Proprietary Name:
Pramipexole Dihydrochloride
Substance 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:
70771132803
NDC to RxNorm Crosswalk:
  • RxCUI: 1114479 - pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1114479 - 24 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral Tablet
  • RxCUI: 1114479 - pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1114485 - pramipexole dihydrochloride 3.75 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1114485 - 24 HR pramipexole dihydrochloride 3.75 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1
    • Pharmacologic Class(es):
  • Dopamine Agonists - [MoA] (Mechanism of Action)
  • Nonergot Dopamine Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202891
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-24-2018
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70771-1328-410 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1328-2)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70771-1328-3?

    The NDC Packaged Code 70771-1328-3 is assigned to a package of 30 tablet, extended release in 1 bottle of Pramipexole Dihydrochloride, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 70771-1328 included in the NDC Directory?

    Yes, Pramipexole Dihydrochloride with product code 70771-1328 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on April 24, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70771-1328-3?

    The 11-digit format is 70771132803. 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 5-4-1 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
    5-4-170771-1328-35-4-270771-1328-03