Rytary Capsule, Extended Release
NDC Package 64896-663-01

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

Rytary (carbidopa and levodopa) capsules is a medication used to treat the symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving) or Parkinson-like conditions. This formulation utilizes a capsule, extended release delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 64896-663 and is authorized under FDA application NDA203312.

Identification & Billing

NDC Package Code
64896-663-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
64896-663
11-Digit Billing Format
64896066301
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: 1600773 - carbidopa 23.75 MG / levodopa 95 MG 8HR Extended Release Oral Capsule
  • RxCUI: 1600773 - 8 HR carbidopa 23.75 MG / levodopa 95 MG Extended Release Oral Capsule
  • RxCUI: 1600773 - 8 HR Carbidopa 23.75 MG / L-DOPA 95 MG Extended Release Oral Capsule
  • RxCUI: 1600773 - carbidopa 23.75 MG / levodopa 95 MG 8 HR Extended Release Oral Capsule
  • RxCUI: 1600774 - RYTARY 23.75 MG / 95 MG 8HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Rytary
Non-Proprietary Name
Carbidopa And Levodopa
Substance Name
Carbidopa Hydrate; Levodopa
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is used to treat the symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving) or Parkinson-like conditions. Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement. Carbidopa prevents the breakdown of levodopa in the bloodstream so more levodopa can enter the brain. Carbidopa can also reduce some of levodopa's side effects such as nausea and vomiting.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA203312
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-12-2015
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 (64896-663). Click a package code to view its specific billing and regulatory data.

64896-663-09
25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
64896-663-43
240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
64896-663-99
100 CAPSULE, EXTENDED RELEASE 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 64896-663-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Rytary, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This capsule, extended release is formulated for oral use and contains carbidopa hydrate; 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 Amneal Pharmaceuticals Llc on January 12, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat the symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving) or Parkinson-like conditions. Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement. Carbidopa prevents the breakdown of levodopa in the bloodstream so more levodopa can enter the brain. Carbidopa can also reduce some of levodopa's side effects such as nausea and vomiting.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64896066301. 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)
64896-663-01
11-Digit CMS (5-4-2)
64896-0663-01

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