Focalin
NDC 16590-649

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 16590-649?
  5. Focalin XR 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 inactivated by the FDA.

Focalin is a NDA-approved product labeled by Stat Rx Usa Llc. This medication is used to treat attention deficit hyperactivity disorder - ADHD. It is supplied as a green product. This product entry covers the primary NDC 16590-649 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
16590-649
Proprietary Name:
Focalin XR
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Stat Rx Usa Llc
Labeler Code:
16590
Product Label ID:
bdb43b40-d34d-47f0-b522-a0ad2d2b1185
FDA Application Number: [6]
NDA021802
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
05-31-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GREEN (C48329)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
NVR;D15
Score:
1

Code Structure Chart

Product Details

What is NDC 16590-649?

The NDC code 16590-649 is assigned by the FDA to the product Focalin XR. This pharmaceutical product is labeled by Stat Rx Usa Llc and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 16590-649-30, 16590-649-60, 16590-649-90. 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. It works by changing the amounts of certain natural substances in the brain. Dexmethylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

Which are the associated UNII Codes?

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

  • DEXMETHYLPHENIDATE HYDROCHLORIDE (UNII: 1678OK0E08)
  • DEXMETHYLPHENIDATE (UNII: M32RH9MFGP) (Active Moiety)

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: 899461 - dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule
  • RxCUI: 899461 - 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule
  • RxCUI: 899461 - dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 899463 - Focalin XR 15 MG 24HR Extended Release Oral Capsule
  • RxCUI: 899463 - 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]

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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 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".