NDC 10135-610 Oxybutynin Chloride

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:
10135-610
Proprietary Name:
Oxybutynin Chloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Marlex Pharmaceuticals Inc
Labeler Code:
10135
Start Marketing Date: [9]
02-01-2016
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327)
PINK (C48328)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
A;31
A;32
Score:
1

Product Packages

NDC Code 10135-610-01

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

NDC Code 10135-610-05

Package Description: 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 10135-610?

The NDC code 10135-610 is assigned by the FDA to the product Oxybutynin Chloride which is product labeled by Marlex Pharmaceuticals Inc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 10135-610-01 100 tablet, extended release in 1 bottle, plastic , 10135-610-05 500 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 Oxybutynin Chloride?

Oxybutynin is used to treat certain bladder and urinary conditions (e.g., overactive bladder). It relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination. Oxybutynin belongs to a class of drugs known as antispasmodics. The manufacturer does not recommend using this medication in children younger than 5 years of age.

Which are Oxybutynin Chloride UNII Codes?

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

Which are Oxybutynin Chloride 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 Oxybutynin Chloride?

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: 863619 - oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 863619 - 24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet
  • RxCUI: 863619 - oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 863628 - oxyBUTYnin chloride 15 MG 24HR Extended Release Oral Tablet
  • RxCUI: 863628 - 24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet

* Please review the disclaimer below.

Patient Education

Oxybutynin


Oxybutynin is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in certain adults and children. Oxybutynin is also used as an extended-release tablet to control bladder muscles in adults and children 6 years of age and older with spina bifida (a disability that occurs when the spinal cord does not close properly before birth), or other nervous system conditions that affect the bladder muscles. Oxybutynin is in a class of medications called anticholinergics/antimuscarinics. It works by relaxing the bladder muscles.
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* 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".