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  4. NDC Product Code: 70370-3025 Ongentys

NDC 70370-3025 Ongentys

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70370-3025?
  5. Ongentys Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 70370-3025 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
70370-3025
Proprietary Name:
Ongentys
Product Type: [3]
Labeler Name: [5]
Neurocrine Biosciences, Inc.
Labeler Code:
70370
Product Label ID:
278a60c4-2353-4657-b486-f392b93181b7
FDA Application Number: [6]
NDA212489
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
04-24-2020
End Marketing Date: [10]
09-30-2024
Listing Expiration Date: [11]
09-30-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE OPAQUE CAP AND LIGHT PINK OPAQUE BODY)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
OPC;25
Score:
1

Code Structure Chart

Product Details

What is NDC 70370-3025?

The NDC code 70370-3025 is assigned by the FDA to the product Ongentys which is product labeled by Neurocrine Biosciences, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 70370-3025-2 30 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Ongentys?

ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

Which are Ongentys UNII Codes?

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

Which are Ongentys Inactive Ingredients 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:

* Please review the disclaimer below.

Patient Education

Opicapone


Opicapone is used along with levodopa and carbidopa (Sinemet, Rytary) to treat the end-of-dose 'wearing-off' symptoms of Parkinson's disease. Opicapone is an inhibitor of catechol-O-methyltransferase (COMT). Opicapone helps the levodopa and carbidopa work better by allowing more of it to reach the brain, where it has its effects.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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.

[12] 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".