Carbidopa, Levodopa And Entacapone Tablet, Film Coated
NDC Package 16571-693-01

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

Package Information

Carbidopa, Levodopa And Entacapone tablets is carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease.Carbidopa, levodopa and entacapone tablets 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 16571-693 and is authorized under FDA application ANDA213212.

Identification & Billing

NDC Package Code
16571-693-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
16571-693
11-Digit Billing Format
16571069301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
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

Clinical Specifications

Proprietary Name
Carbidopa, Levodopa And Entacapone
Non-Proprietary Name
Carbidopa, Levodopa And Entacapone
Substance Name
Carbidopa; Entacapone; Levodopa
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease.Carbidopa, levodopa and entacapone tablets 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.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213212
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-05-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 16571-693-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Carbidopa, Levodopa And Entacapone, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This tablet, film coated is formulated for oral use and contains carbidopa; entacapone; 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 Rising Pharma Holdings, Inc. on August 05, 2021. The current certification is valid through December 31, 2027.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16571069301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
16571-693-01
11-Digit CMS (5-4-2)
16571-0693-01

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