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  5. NDC Package Code: 43547-314-09 Valsartan And Hydrochlorothiazide

NDC Package 43547-314-09 Valsartan And Hydrochlorothiazide

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43547-314-09
Package Description:
90 TABLET, FILM COATED in 1 BOTTLE
Product Code:
43547-314
Proprietary Name:
Valsartan And Hydrochlorothiazide
Non-Proprietary Name:
Valsartan And Hydrochlorothiazide
Substance Name:
Hydrochlorothiazide; Valsartan
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.
11-Digit NDC Billing Format:
43547031409
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Solco Healthcare Us, Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • HYDROCHLOROTHIAZIDE 12.5 mg/1
  • VALSARTAN 320 mg/1
    • Pharmacologic Class(es):
  • Angiotensin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Angiotensin 2 Receptor Blocker - [EPC] (Established Pharmacologic Class)
  • Increased Diuresis - [PE] (Physiologic Effect)
  • Thiazide Diuretic - [EPC] (Established Pharmacologic Class)
  • Thiazides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA206083
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-31-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43547-314-0330 TABLET, FILM COATED in 1 BOTTLE
    43547-314-50500 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43547-314-09?

    The NDC Packaged Code 43547-314-09 is assigned to a package of 90 tablet, film coated in 1 bottle of Valsartan And Hydrochlorothiazide, a human prescription drug labeled by Solco Healthcare Us, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 43547-314 included in the NDC Directory?

    Yes, Valsartan And Hydrochlorothiazide with product code 43547-314 is active and included in the NDC Directory. The product was first marketed by Solco Healthcare Us, Llc on October 31, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43547-314-09?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 90.

    What is the 11-digit format for NDC 43547-314-09?

    The 11-digit format is 43547031409. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243547-314-095-4-243547-0314-09