Rytary Capsule, Extended Release
NDC 64896-661

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64896-661?
  5. Rytary Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Rytary (carbidopa and levodopa) is a NDA-approved product labeled by Amneal Pharmaceuticals Llc. This medication is used to treat the symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving) or Parkinson-like conditions. It is supplied as a blue capsule, extended release for oral administration. This product entry covers the primary NDC 64896-661 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
64896-661
Proprietary Name:
Rytary
Non-Proprietary Name: [1]
Carbidopa And Levodopa
Substance Name: [2]
Carbidopa Hydrate; Levodopa
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

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(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Amneal Pharmaceuticals Llc
Labeler Code:
64896
Product Label ID:
6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7
FDA Application Number: [6]
NDA203312
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-12-2015
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BLUE (C48333)
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
IPX066;95
Score:
1

Code Structure Chart

Product Details

What is NDC 64896-661?

The NDC code 64896-661 is assigned by the FDA to the product Rytary. It is commonly known by its generic name, carbidopa and levodopa. This pharmaceutical product is labeled by Amneal Pharmaceuticals Llc and is currently categorized as listed product. The medication is a capsule, extended release administered via oral route. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 64896-661-01, 64896-661-09, 64896-661-43, 64896-661-99. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CARBIDOPA HYDRATE 23.75 mg/1
  • LEVODOPA 95 mg/1 - The naturally occurring form of DIHYDROXYPHENYLALANINE and the immediate precursor of DOPAMINE. Unlike dopamine itself, it can be taken orally and crosses the blood-brain barrier. It is rapidly taken up by dopaminergic neurons and converted to DOPAMINE. It is used for the treatment of PARKINSONIAN DISORDERS and is usually given with agents that inhibit its conversion to dopamine outside of the central nervous system.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Levodopa and Carbidopa


The combination of levodopa and carbidopa is used to treat the symptoms of Parkinson's disease and Parkinson's-like symptoms that may develop after encephalitis (swelling of the brain) or injury to the nervous system caused by carbon monoxide poisoning or manganese poisoning. Parkinson's symptoms, including tremors (shaking), stiffness, and slowness of movement, are caused by a lack of dopamine, a natural substance usually found in the brain. Levodopa is in a class of medications called central nervous system agents. It works by being converted to dopamine in the brain. Carbidopa is in a class of medications called decarboxylase inhibitors. It works by preventing levodopa from being broken down before it reaches the brain. This allows for a lower dose of levodopa, which causes less nausea and vomiting.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".