NDC 70754-162 Darifenacin

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:
70754-162
Proprietary Name:
Darifenacin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
70754
Start Marketing Date: [9]
04-19-2022
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
PINK (C48328)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
AL;110
AL;111
Score:
1

Code Structure Chart

Product Details

What is NDC 70754-162?

The NDC code 70754-162 is assigned by the FDA to the product Darifenacin which is product labeled by Alan Laboratories, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 70754-162-03 30 tablet, film coated, extended release in 1 bottle , 70754-162-50 500 tablet, film coated, extended release 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 Darifenacin?

Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Which are Darifenacin UNII Codes?

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

Which are Darifenacin 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 Darifenacin?

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: 485421 - darifenacin 15 MG 24HR Extended Release Oral Tablet
  • RxCUI: 485421 - 24 HR darifenacin 15 MG Extended Release Oral Tablet
  • RxCUI: 485421 - darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 485423 - darifenacin 7.5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 485423 - 24 HR darifenacin 7.5 MG Extended Release Oral Tablet

* Please review the disclaimer below.

Patient Education

Darifenacin


Darifenacin is used to treat an overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Darifenacin is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.
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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".