NDC 54868-3454 Methylphenidate Hydrochloride

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:
54868-3454
Proprietary Name:
Methylphenidate Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Start Marketing Date: [9]
12-16-1994
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

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

Product Packages

NDC Code 54868-3454-0

Package Description: 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 54868-3454-1

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

NDC Code 54868-3454-2

Package Description: 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 54868-3454-3

Package Description: 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 54868-3454-4

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

NDC Code 54868-3454-5

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

NDC Code 54868-3454-6

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

Product Details

What is NDC 54868-3454?

The NDC code 54868-3454 is assigned by the FDA to the product Methylphenidate Hydrochloride which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 7 packages with assigned NDC codes 54868-3454-0 50 tablet, extended release in 1 bottle, plastic , 54868-3454-1 60 tablet, extended release in 1 bottle, plastic , 54868-3454-2 20 tablet, extended release in 1 bottle, plastic , 54868-3454-3 100 tablet, extended release in 1 bottle, plastic , 54868-3454-4 30 tablet, extended release in 1 bottle, plastic , 54868-3454-5 10 tablet, extended release in 1 bottle, plastic , 54868-3454-6 90 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 Methylphenidate Hydrochloride?

Attention Deficit Disorders, NarcolepsyAttention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.Special Diagnostic ConsiderationsSpecific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.

Which are Methylphenidate Hydrochloride UNII Codes?

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

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

Which are Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride?

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

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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".