Lisinopril And Hydrochlorothiazide
NDC Package 16590-308-60

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.

Lisinopril And Hydrochlorothiazide is tablets USP are indicated for the treatment of hypertension.These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-308 and is authorized under FDA application ANDA077912.

Identification & Billing

NDC Package Code
16590-308-60
Package Description
60 TABLET in 1 BOTTLE
Product Code
16590-308
11-Digit Billing Format
16590030860
RxNorm Crosswalk
  • RxCUI: 197886 - lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 197886 - hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet
  • RxCUI: 197886 - HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet
  • RxCUI: 197887 - lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet
  • RxCUI: 197887 - hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet

Clinical Specifications

Proprietary Name
Lisinopril And Hydrochlorothiazide
Dosage Form
-
Usage Information
Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension.These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.)In considering use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema.)

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
ANDA077912
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-04-2006
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 (16590-308). Click a package code to view its specific billing and regulatory data.

16590-308-30
30 TABLET in 1 BOTTLE
16590-308-90
90 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 16590-308-60 identifies a specific commercial package of 60 tablet in 1 bottle of Lisinopril And Hydrochlorothiazide, labeled by Stat Rx Usa Llc. 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 Stat Rx Usa Llc on October 04, 2006. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590030860. 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)
16590-308-60
11-Digit CMS (5-4-2)
16590-0308-60

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