NDC 64725-0515 Intuniv

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
64725-0515
Proprietary Name:
Intuniv
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Tya Pharmaceuticals
Labeler Code:
64725
Start Marketing Date: [9]
09-02-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape:
OVAL (C48345)
Size(s):
12 MM
Imprint(s):
503;2MG
Score:
1

Product Packages

NDC Code 64725-0515-1

Package Description: 30 TABLET, EXTENDED RELEASE in 1 CONTAINER

Product Details

What is NDC 64725-0515?

The NDC code 64725-0515 is assigned by the FDA to the product Intuniv which is product labeled by Tya Pharmaceuticals. The product's dosage form is . The product is distributed in a single package with assigned NDC code 64725-0515-1 30 tablet, extended release in 1 container . 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 Intuniv?

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 Intuniv UNII Codes?

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

Which are Intuniv 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:

What is the NDC to RxNorm Crosswalk for Intuniv?

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: 862006 - guanFACINE 1 MG 24HR Extended Release Oral Tablet
  • RxCUI: 862006 - 24 HR guanfacine 1 MG Extended Release Oral Tablet
  • RxCUI: 862006 - guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 862006 - guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 862010 - intuniv 1 MG 24HR Extended Release Oral Tablet

* 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.

[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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".