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  4. NDC Product Code: 54868-4489 Concerta

NDC 54868-4489 Concerta

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-4489?
  5. Concerta 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.
NDC Product Code:
54868-4489
Proprietary Name:
Concerta
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
f63155b9-ea71-4a30-be32-37173f87bcbf
Start Marketing Date: [9]
03-21-2003
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW)
Shape:
OVAL (C48345)
Size(s):
12 MM
Imprint(s):
ALZA;18
Score:
1

Product Packages

NDC Code 54868-4489-0

Package Description: 10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 54868-4489-1

Package Description: 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 54868-4489-2

Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 54868-4489-3

Package Description: 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 54868-4489?

The NDC code 54868-4489 is assigned by the FDA to the product Concerta which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 54868-4489-0 10 tablet, extended release in 1 bottle, plastic , 54868-4489-1 90 tablet, extended release in 1 bottle, plastic , 54868-4489-2 30 tablet, extended release in 1 bottle, plastic , 54868-4489-3 60 tablet, extended release in 1 bottle, plastic . 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 Concerta?

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.

Which are Concerta UNII Codes?

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

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

Which are Concerta 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 Concerta?

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: 1091155 - methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1091155 - 24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet
  • RxCUI: 1091155 - methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1091157 - CONCERTA 18 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1091157 - 24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet [Concerta]

* 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".