Losartan Potassium And Hydrochlorothiazide
NDC Package 68258-6031-9

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

Package Information

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

Losartan Potassium And Hydrochlorothiazide is hypertension      Losartan Potassium and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-6031 and is authorized under FDA application ANDA090528.

Identification & Billing

NDC Package Code
68258-6031-9
Package Description
90 TABLET in 1 BOTTLE
Product Code
68258-6031
11-Digit Billing Format
68258603109
RxNorm Crosswalk
  • RxCUI: 979464 - losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 979464 - hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral Tablet
  • RxCUI: 979464 - HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet
  • RxCUI: 979464 - HCTZ 12.5 MG / Losartan Pot 100 MG Oral Tablet
  • RxCUI: 979464 - HCTZ 12.5 MG / losartan potassium 100 MG Oral Tablet

Clinical Specifications

Proprietary Name
Losartan Potassium And Hydrochlorothiazide
Dosage Form
-
Usage Information
Hypertension      Losartan Potassium and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION). Hypertensive Patients with Left Ventricular Hypertrophy      Losartan Potassium and Hydrochlorothiazide Tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race, and DOSAGE AND ADMINISTRATION).

Regulatory & Marketing

Labeler Name
Dispensing Solutions, Inc.
FDA Application #
ANDA090528
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-06-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68258-6031-9 identifies a specific commercial package of 90 tablet in 1 bottle of Losartan Potassium And Hydrochlorothiazide, labeled by Dispensing Solutions, Inc.. 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 Dispensing Solutions, Inc. on April 06, 2010. The current certification is valid through December 31, 2017.

How is this Dispensing Solutions, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258603109. 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 (5-4-1)
68258-6031-9
11-Digit CMS (5-4-2)
68258-6031-09

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