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  4. NDC Product Code: 55648-738 Alfuzosin Hydrochloride

NDC 55648-738 Alfuzosin Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55648-738?
  5. Alfuzosin 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:
55648-738
Proprietary Name:
Alfuzosin Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Wockhardt Limited
Labeler Code:
55648
Product Label ID:
30f97b8e-4486-4b5f-896a-d7dfa1e2e33a
FDA Application Number: [6]
ANDA090221
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
08-15-2012
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
YELLOW (C48330 - YELLOW)
Shape:
ROUND (C48348)
Size(s):
20 MM
Imprint(s):
W738
Score:
1

Code Structure Chart

Product Details

What is NDC 55648-738?

The NDC code 55648-738 is assigned by the FDA to the product Alfuzosin Hydrochloride which is product labeled by Wockhardt Limited. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 55648-738-01 30 tablet in 1 bottle , 55648-738-02 100 tablet in 1 bottle , 55648-738-03 500 tablet in 1 bottle , 55648-738-05 10 blister pack in 1 carton / 10 tablet in 1 blister pack. 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 Alfuzosin Hydrochloride?

Alfuzosin HCl extended-release tablets are not indicated for the treatment of hypertension. Alfuzosin HCl extended-release tablets are not indicated for use in the pediatric population.

Which are Alfuzosin Hydrochloride UNII Codes?

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

Which are Alfuzosin 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 Alfuzosin 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: 861132 - alfuzosin HCl 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 861132 - 24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet
  • RxCUI: 861132 - alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral Tablet

* 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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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".