Metadate Er
NDC 53014-594
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Metadate Er is a ANDA-approved product labeled by Unither Manufacturing, Llc. This medication is used to treat attention deficit hyperactivity disorder - ADHD. It is supplied as a white product. This product entry covers the primary NDC 53014-594 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
53014-594
Proprietary Name:
Metadate Er
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
53014
Product Label ID:
FDA Application Number: [6]
ANDA089601
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
06-01-1988
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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 53014-594?
The NDC code 53014-594 is assigned by the FDA to the product Metadate Er. This pharmaceutical product is labeled by Unither Manufacturing, Llc 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: 53014-594-07. 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. 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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI)
- METHYLPHENIDATE (UNII: 207ZZ9QZ49) (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:
- CETYL ALCOHOL (UNII: 936JST6JCN)
- ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
- ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
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: 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 full disclaimer at the bottom of this page.
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".
