Amlodipine, Valsartan, Hydrochlorothiazide Tablet, Film Coated
NDC Package 51407-671-30

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

Package Information

Amlodipine, Valsartan, Hydrochlorothiazide (amlodipine besylate valsartan hydrochlorothiazide) tablets is amlodipine/valsartan/hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. This formulation utilizes a tablet, film coated delivery system. Marketed by Golden State Medical Supply, Inc., this product is identified by NDC 51407-671 and is authorized under FDA application ANDA201087.

Identification & Billing

NDC Package Code
51407-671-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
51407-671
11-Digit Billing Format
51407067130
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 848131 - amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 848131 - amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 848131 - amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 848131 - amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 848135 - amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Amlodipine, Valsartan, Hydrochlorothiazide
Non-Proprietary Name
Amlodipine Besylate Valsartan Hydrochlorothiazide
Substance Name
Amlodipine Besylate; 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
Amlodipine/valsartan/hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide.Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.Limitation of UseAmlodipine/valsartan/hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].

Regulatory & Marketing

Labeler Name
Golden State Medical Supply, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA201087
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2015
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51407-671-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Amlodipine, Valsartan, Hydrochlorothiazide, a human prescription drug labeled by Golden State Medical Supply, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated is formulated for oral use and contains amlodipine besylate; 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 Golden State Medical Supply, Inc. on June 01, 2015. The current certification is valid through December 31, 2026.

How is this Golden State Medical Supply, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51407067130. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
51407-671-30
11-Digit CMS (5-4-2)
51407-0671-30

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