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  4. NDC Product Code: 69452-169 Dexmethylphenidate Hydrochloride

NDC 69452-169 Dexmethylphenidate Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69452-169?
  5. Dexmethylphenidate Hydrochloride 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:
69452-169
Proprietary Name:
Dexmethylphenidate Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Bionpharma Inc.
Labeler Code:
69452
Product Label ID:
8b379f0f-8622-49c8-9cdc-3bb4cf2d92fd
Start Marketing Date: [9]
01-04-2022
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT YELLOW TO BEIGE)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
FD2
Score:
1

Code Structure Chart

Product Details

What is NDC 69452-169?

The NDC code 69452-169 is assigned by the FDA to the product Dexmethylphenidate Hydrochloride which is product labeled by Bionpharma Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69452-169-20 100 tablet 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 Dexmethylphenidate Hydrochloride?

Hypersensitivity to methylphenidate or other components of Dexmethylphenidate hydrochloride tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions( 6.1)] . Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MOAI, because of the risk of hypertensive crises [see Drug Interactions( 7.1)].

Which are Dexmethylphenidate Hydrochloride UNII Codes?

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

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

Which are Dexmethylphenidate 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 Dexmethylphenidate 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:

* 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".