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  5. NDC Package Code: 78206-166-01 Sinemet

NDC Package 78206-166-01 Sinemet

Carbidopa And Levodopa Tablet 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:
78206-166-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
78206-166
Proprietary Name:
Sinemet
Non-Proprietary Name:
Carbidopa And Levodopa
Substance Name:
Carbidopa; Levodopa
Usage Information:
SINEMET is indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on SINEMET. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.
11-Digit NDC Billing Format:
78206016601
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 197443 - carbidopa 10 MG / levodopa 100 MG Oral Tablet
  • RxCUI: 197443 - carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral Tablet
  • RxCUI: 197443 - Carbidopa 10 MG / L-DOPA 100 MG Oral Tablet
  • RxCUI: 197444 - carbidopa 25 MG / levodopa 100 MG Oral Tablet
  • RxCUI: 197444 - carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Organon Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CARBIDOPA 10 mg/1
  • LEVODOPA 100 mg/1
    • Pharmacologic Class(es):
  • Amino Acids, Aromatic - [CS]
  • Aromatic Amino Acid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA017555
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2021
    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.

    Frequently Asked Questions

    What is NDC 78206-166-01?

    The NDC Packaged Code 78206-166-01 is assigned to a package of 100 tablet in 1 bottle of Sinemet, a human prescription drug labeled by Organon Llc. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

    Is NDC 78206-166 included in the NDC Directory?

    Yes, Sinemet with product code 78206-166 is active and included in the NDC Directory. The product was first marketed by Organon Llc on June 01, 2021 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 NDC billing unit for package 78206-166-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 78206-166-01?

    The 11-digit format is 78206016601. 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
    5-3-278206-166-015-4-278206-0166-01