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  5. NDC Package Code: 0378-0078-01 Carbidopa And Levodopa

NDC Package 0378-0078-01 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:
0378-0078-01
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
0378-0078
Proprietary Name:
Carbidopa And Levodopa
Non-Proprietary Name:
Carbidopa And Levodopa
Substance Name:
Carbidopa; Levodopa
Usage Information:
Carbidopa and levodopa tablets, USP are 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 carbidopa and levodopa tablets. 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:
00378007801
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:
    Mylan Pharmaceuticals Inc.
    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:
    ANDA090324
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-16-2011
    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 0378-0078-01?

    The NDC Packaged Code 0378-0078-01 is assigned to a package of 100 tablet in 1 bottle, plastic of Carbidopa And Levodopa, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0378-0078 included in the NDC Directory?

    Yes, Carbidopa And Levodopa with product code 0378-0078 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on May 16, 2011 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 0378-0078-01?

    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 0378-0078-01?

    The 11-digit format is 00378007801. 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
    4-4-20378-0078-015-4-200378-0078-01