Valsartan And Hydrochlorothiazide Tablet, Film Coated
NDC Package 43547-313-50

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

Valsartan And Hydrochlorothiazide tablets is •Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. This formulation utilizes a tablet, film coated delivery system. Marketed by Solco Healthcare Us, Llc, this product is identified by NDC 43547-313 and is authorized under FDA application ANDA206083.

Identification & Billing

NDC Package Code
43547-313-50
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
43547-313
11-Digit Billing Format
43547031350
RxNorm Crosswalk
  • RxCUI: 200284 - HCTZ 12.5 MG / valsartan 80 MG Oral Tablet
  • RxCUI: 200284 - hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet
  • RxCUI: 200285 - valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 200285 - hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 200285 - HCTZ 12.5 MG / valsartan 160 MG Oral Tablet

Clinical Specifications

Proprietary Name
Valsartan And Hydrochlorothiazide
Non-Proprietary Name
Valsartan And Hydrochlorothiazide
Substance Name
Hydrochlorothiazide; Valsartan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin.•Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.

Regulatory & Marketing

Labeler Name
Solco Healthcare Us, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA206083
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2015
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 (43547-313). Click a package code to view its specific billing and regulatory data.

43547-313-03
30 TABLET, FILM COATED in 1 BOTTLE
43547-313-09
90 TABLET, FILM COATED 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 43547-313-50 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Valsartan And Hydrochlorothiazide, a human prescription drug labeled by Solco Healthcare Us, Llc. This tablet, film coated is formulated for oral use and contains hydrochlorothiazide; valsartan 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 Solco Healthcare Us, Llc on October 31, 2015. The current certification is valid through December 31, 2027.

How is this Solco Healthcare Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43547031350. 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)
43547-313-50
11-Digit CMS (5-4-2)
43547-0313-50

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