Carbidopa And Levodopa
NDC Package 43353-202-80

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Carbidopa And Levodopa is 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. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-202 and is authorized under FDA application ANDA090324.

Identification & Billing

NDC Package Code
43353-202-80
Package Description
180 TABLET in 1 BOTTLE, PLASTIC
Product Code
43353-202
11-Digit Billing Format
43353020280
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
180 EA
RxNorm Crosswalk
  • RxCUI: 197444 - carbidopa 25 MG / levodopa 100 MG Oral Tablet
  • RxCUI: 197444 - carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral Tablet
  • RxCUI: 197444 - Carbidopa 25 MG / L-DOPA 100 MG Oral Tablet

Clinical Specifications

Proprietary Name
Carbidopa And Levodopa
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
ANDA090324
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-08-2016
Listing Expiration
12-31-2022
Exclude Flag
I
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 (43353-202). Click a package code to view its specific billing and regulatory data.

43353-202-60
90 TABLET in 1 BOTTLE, PLASTIC

* 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 43353-202-80 identifies a specific commercial package of 180 tablet in 1 bottle, plastic of Carbidopa And Levodopa, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 180 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on February 08, 2016. The current certification is valid through December 31, 2022.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353020280. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 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)
43353-202-80
11-Digit CMS (5-4-2)
43353-0202-80

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