Fosinopril Sodium And Hydrochlorothiazide Tablet
NDC Package 69097-973-07

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

Package Information

Fosinopril Sodium And Hydrochlorothiazide tablets are indicated for the treatment of hypertension.These fixed dose combinations are not indicated for initial therapy. This formulation utilizes a tablet delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-973 and is authorized under FDA application ANDA090228.

Identification & Billing

NDC Package Code
69097-973-07
Package Description
100 TABLET in 1 BOTTLE
Product Code
69097-973
11-Digit Billing Format
69097097307
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 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
Non-Proprietary Name
Fosinopril Sodium And Hydrochlorothiazide
Substance Name
Fosinopril Sodium; Hydrochlorothiazide
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)
Pharmacologic Class
Usage Information
Fosinopril sodium and hydrochlorothiazide tablets are 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, 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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090228
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69097-973-07 identifies a specific commercial package of 100 tablet in 1 bottle of Fosinopril Sodium And Hydrochlorothiazide, a human prescription drug labeled by Cipla Usa Inc.. This tablet is formulated for oral use and contains fosinopril sodium; hydrochlorothiazide 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 Cipla Usa Inc. on July 24, 2020. The current certification is valid through December 31, 2026.

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097097307. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
69097-973-07
11-Digit CMS (5-4-2)
69097-0973-07

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