Intuniv
NDC 54092-520

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54092-520?
  5. Intuniv Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

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

Intuniv is a NDA-approved product labeled by Takeda Pharmaceuticals America, Inc.. This medication is used to treat attention deficit hyperactivity disorder (ADHD), as part of a total treatment plan including psychological, educational, and social measures. It is supplied as a white product. This product entry covers the primary NDC 54092-520 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54092-520
Proprietary Name:
Intuniv
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Takeda Pharmaceuticals America, Inc.
Labeler Code:
54092
Product Label ID:
b972af81-3a37-40be-9fe1-3ddf59852528
FDA Application Number: [6]
NDA022037
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-02-2009
End Marketing Date: [10]
10-29-2015
Listing Expiration Date: [11]
10-29-2015
Exclude Flag: [12]
D

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
GREEN (C48329 - GREEN)
WHITE (C48325)
Shape:
ROUND (C48348)
OVAL (C48345)
Size(s):
7 MM
12 MM
8 MM
Imprint(s):
503;1MG
503;2MG
503;3MG
503;4MG
Score:
1

Code Structure Chart

Product Details

What is NDC 54092-520?

The NDC code 54092-520 is assigned by the FDA to the product Intuniv. This pharmaceutical product is labeled by Takeda Pharmaceuticals America, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54092-520-01. 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 attention deficit hyperactivity disorder (ADHD), as part of a total treatment plan including psychological, educational, and social measures. Unlike other drugs used to treat ADHD, guanfacine is not a stimulant. The exact way that guanfacine works to treat ADHD is unknown. Guanfacine is thought to affect receptors in the parts of the brain that lead to strengthening working memory, reducing distraction, and improving attention and impulse control. Guanfacine may help lessen ADHD symptoms such as being disruptive, inattentive, hyperactive, impulsive, and arguing with adults or losing one's temper.

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: 1092566 - {7 (24 HR guanfacine 1 MG Extended Release Oral Tablet) / 7 (24 HR guanfacine 2 MG Extended Release Oral Tablet) } Pack
  • RxCUI: 1092566 - guanFACINE 1 MG 24HR Extended Release Oral Tablet (7) / guanFACINE 2 MG 24HR Extended Release Oral Tablet (7) Pack
  • RxCUI: 1092567 - {7 (24 HR guanfacine 1 MG Extended Release Oral Tablet [Intuniv]) / 7 (24 HR guanfacine 2 MG Extended Release Oral Tablet [Intuniv]) } Pack [Intuniv Kit 7/7]
  • RxCUI: 1092567 - Intuniv Kit 7/7
  • RxCUI: 862006 - guanFACINE 1 MG 24HR Extended Release Oral Tablet

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Product & Regulatory Definitions
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 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.
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".