Carbidopa And Levodopa Tablet
NDC Package 42291-488-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Carbidopa And Levodopa tablets 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. This formulation utilizes a tablet delivery system. Marketed by Avkare, this product is identified by NDC 42291-488 and is authorized under FDA application ANDA074260.

Identification & Billing

NDC Package Code
42291-488-10
Package Description
1000 TABLET in 1 BOTTLE
Product Code
42291-488
11-Digit Billing Format
42291048810
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
RxNorm Crosswalk
  • RxCUI: 197445 - carbidopa 25 MG / levodopa 250 MG Oral Tablet
  • RxCUI: 197445 - carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral Tablet
  • RxCUI: 197445 - Carbidopa 25 MG / L-DOPA 250 MG Oral Tablet

Clinical Specifications

Proprietary Name
Carbidopa And Levodopa
Non-Proprietary Name
Carbidopa And Levodopa
Substance Name
Carbidopa; Levodopa
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Carbidopa and levodopa tablets 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. 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.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA074260
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-21-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42291-488). Click a package code to view its specific billing and regulatory data.

42291-488-01
100 TABLET in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-488-10 identifies a specific commercial package of 1000 tablet in 1 bottle of Carbidopa And Levodopa, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 1000 billable units per package. This tablet is formulated for oral use and contains carbidopa; levodopa as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avkare on February 21, 2024. The current certification is valid through December 31, 2027.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291048810. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42291-488-10
11-Digit CMS (5-4-2)
42291-0488-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.