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  5. NDC Package Code: 52427-809-01 Stalevo

NDC Package 52427-809-01 Stalevo

Carbidopa,Levodopa,And Entacapone Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

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:
52427-809-01
Package Description:
1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
52427-809
Proprietary Name:
Stalevo
Non-Proprietary Name:
Carbidopa, Levodopa, And Entacapone
Substance Name:
Carbidopa; Entacapone; Levodopa
Usage Information:
Stalevo is indicated for the treatment of Parkinson's disease.Stalevo can be used: To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.
11-Digit NDC Billing Format:
52427080901
NDC to RxNorm Crosswalk:
  • RxCUI: 403850 - carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral Tablet
  • RxCUI: 403850 - carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral Tablet
  • RxCUI: 403850 - Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral Tablet
  • RxCUI: 403851 - carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral Tablet
  • RxCUI: 403851 - carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Almatica Pharma Llc
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):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA021485
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
10-05-2020
End Marketing Date:
02-28-2026
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 52427-809-01?

The NDC Packaged Code 52427-809-01 is assigned to a package of 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle of Stalevo, a human prescription drug labeled by Almatica Pharma Llc. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 52427-809 included in the NDC Directory?

Yes, Stalevo with product code 52427-809 is active and included in the NDC Directory. The product was first marketed by Almatica Pharma Llc on October 05, 2020.

What is the 11-digit format for NDC 52427-809-01?

The 11-digit format is 52427080901. 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
5-3-252427-809-015-4-252427-0809-01