Valsartan Solution
NDC Package 70954-310-10

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 solution is valsartan is used to treat high blood pressure and heart failure. This formulation utilizes a solution delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 70954-310 and is authorized under FDA application ANDA214102.

Identification & Billing

NDC Package Code
70954-310-10
Package Description
120 mL in 1 BOTTLE, PLASTIC
Product Code
70954-310
11-Digit Billing Format
70954031010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valsartan
Non-Proprietary Name
Valsartan
Substance Name
Valsartan
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VALSARTAN 4 mg/mL
Pharmacologic Class
Usage Information
Valsartan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

Regulatory & Marketing

Labeler Name
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214102
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-02-2021
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.

* 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 (70954-310). Click a package code to view its specific billing and regulatory data.

70954-310-20
473 mL in 1 BOTTLE, PLASTIC

* 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 70954-310-10 identifies a specific commercial package of 120 ml in 1 bottle, plastic of Valsartan, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 120 billable units per package. This solution is formulated for oral use and contains 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 Ani Pharmaceuticals, Inc. on November 02, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Valsartan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

How is this Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70954031010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 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)
70954-310-10
11-Digit CMS (5-4-2)
70954-0310-10

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