NDC 65580-594 Metadate Er

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:
65580-594
Proprietary Name:
Metadate Er
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
65580
Start Marketing Date: [9]
11-01-2014
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
562;MD
Score:
1

Code Structure Chart

Product Details

What is NDC 65580-594?

The NDC code 65580-594 is assigned by the FDA to the product Metadate Er which is product labeled by Upstate Pharma, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 65580-594-01 100 tablet, extended release 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 Metadate Er?

This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate 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. This medication is also used to treat a certain sleep disorder (narcolepsy).

Which are Metadate Er UNII Codes?

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

  • METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI)
  • METHYLPHENIDATE (UNII: 207ZZ9QZ49) (Active Moiety)

Which are Metadate Er 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 Metadate Er?

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: 1091225 - methylphenidate HCl 20 MG 8HR Extended Release Oral Tablet
  • RxCUI: 1091225 - 8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet
  • RxCUI: 1091225 - methylphenidate HCl 20 MG 8 HR Extended Release Oral Tablet
  • RxCUI: 1091488 - Metadate ER 20 MG 8HR Extended Release Oral Tablet
  • RxCUI: 1091488 - 8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet [Metadate]

* Please review the disclaimer below.

Patient Education

Methylphenidate


Methylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Methylphenidate (Methylin) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Methylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the brain.
[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.

[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".