Fosinopril Sodium And Hydrochlorothiazide
NDC Package 63304-404-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Fosinopril Sodium And Hydrochlorothiazide is tablets, USP is indicated for the treatment of hypertension. Marketed by Ranbaxy Pharmaceuticals Inc., this product is identified by NDC 63304-404 and is authorized under FDA application ANDA076739.

Identification & Billing

NDC Package Code
63304-404-01
Package Description
10 TABLET in 1 BOTTLE
Product Code
63304-404
11-Digit Billing Format
63304040401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk
  • RxCUI: 857166 - fosinopril sodium 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 857166 - fosinopril sodium 10 MG / hydrochlorothiazide 12.5 MG Oral Tablet
  • RxCUI: 857166 - FNP Sodium 10 MG / HCTZ 12.5 MG Oral Tablet
  • RxCUI: 857166 - fosinopril sodium 10 MG / HCTZ 12.5 MG Oral Tablet
  • RxCUI: 857174 - fosinopril sodium 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Fosinopril Sodium And Hydrochlorothiazide
Dosage Form
-
Usage Information
Fosinopril sodium and hydrochlorothiazide tablets, USP is indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION.) In using fosinopril sodium and hydrochlorothiazide tablets, USP, 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 does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis). 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
Ranbaxy Pharmaceuticals Inc.
FDA Application #
ANDA076739
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-20-2004
Listing Expiration
12-31-2017
Exclude Flag
I
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 (63304-404). Click a package code to view its specific billing and regulatory data.

63304-404-10
1000 TABLET in 1 BOTTLE
63304-404-30
30 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 63304-404-01 identifies a specific commercial package of 10 tablet in 1 bottle of Fosinopril Sodium And Hydrochlorothiazide, labeled by Ranbaxy Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Ranbaxy Pharmaceuticals Inc. on December 20, 2004. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304040401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
63304-404-01
11-Digit CMS (5-4-2)
63304-0404-01

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