Fosinopril Sodium Tablet
NDC Package 76282-201-90

11-digit billing NDC: 76282020190 · Billing unit: EA · 90 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fosinopril Sodium tablets are indicated for the treatment of hypertension. This formulation utilizes a tablet delivery system. Marketed by Exelan Pharmaceuticals, Inc., this product is identified by NDC 76282-201 and is authorized under FDA application ANDA077222.

Identification & Billing

NDC Package Code
76282-201-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
76282-201
11-Digit Billing Format
76282020190
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fosinopril Sodium
Non-Proprietary Name
Fosinopril Sodium
Substance Name
Fosinopril Sodium
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FOSINOPRIL SODIUM 20 mg/1
Pharmacologic Class
Usage Information
Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS).In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077222
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-21-2005
Listing Expiration
12-31-2027
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 (76282-201). Click a package code to view its specific billing and regulatory data.

76282-201-10
1000 TABLET 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 76282-201-90 identifies a specific commercial package of 90 tablet in 1 bottle of Fosinopril Sodium, a human prescription drug labeled by Exelan Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains fosinopril sodium 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 June 21, 2005. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282020190. 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)
76282-201-90
11-Digit CMS (5-4-2)
76282-0201-90

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