Alfuzosin Hydrochloride Tablet, Extended Release
NDC Package 76282-302-90

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Alfuzosin Hydrochloride tablets is uSP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. This formulation utilizes a tablet, extended release delivery system. Marketed by Exelan Pharmaceuticals Inc., this product is identified by NDC 76282-302 and is authorized under FDA application ANDA090284.

Identification & Billing

NDC Package Code
76282-302-90
Package Description
90 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
76282-302
11-Digit Billing Format
76282030290
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Alfuzosin Hydrochloride
Non-Proprietary Name
Alfuzosin Hydrochloride
Substance Name
Alfuzosin Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALFUZOSIN HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Alfuzosin hydrochloride tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090284
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-02-2012
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76282-302). Click a package code to view its specific billing and regulatory data.

76282-302-01
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
76282-302-05
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
76282-302-10
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE
76282-302-12
120 TABLET, EXTENDED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76282-302-90 identifies a specific commercial package of 90 tablet, extended release in 1 bottle of Alfuzosin Hydrochloride, a human prescription drug labeled by Exelan Pharmaceuticals Inc.. This tablet, extended release is formulated for oral use and contains alfuzosin hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Exelan Pharmaceuticals Inc. on October 02, 2012. The current certification is valid through December 31, 2026.

How is this Exelan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282030290. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76282-302-90
11-Digit CMS (5-4-2)
76282-0302-90

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.