Sacubitril/valsartan Powder
NDC Package 62512-0085-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Sacubitril/valsartan powders is a medication used to treat certain types of heart failure. This formulation utilizes a powder delivery system. Marketed by Amoli Organics (a Division Of Umedica Laboratories Pvt. Ltd.), this product is identified by NDC 62512-0085.

Identification & Billing

NDC Package Code
62512-0085-0
Package Description
50 kg in 1 DRUM
Product Code
62512-0085
11-Digit Billing Format
62512008500

Clinical Specifications

Proprietary Name
Sacubitril/valsartan
Non-Proprietary Name
Sacubitril/valsartan
Substance Name
Sacubitril Valsartan
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
SACUBITRIL VALSARTAN 1 kg/kg
Usage Information
This product is used to treat certain types of heart failure. It may help you live longer and lower your chance of having to go to the hospital for heart failure. This product contains 2 medications: sacubitril and valsartan. Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). They work by relaxing blood vessels so that blood can flow more easily, which makes it easier for your heart to pump blood to your body.

Regulatory & Marketing

Labeler Name
Amoli Organics (a Division Of Umedica Laboratories Pvt. Ltd.)
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-01-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 62512-0085-0 identifies a specific commercial package of 50 kg in 1 drum of Sacubitril/valsartan (UNFINISHED drug), a bulk ingredient labeled by Amoli Organics (a Division Of Umedica Laboratories Pvt. Ltd.). This powder is formulated for use and contains sacubitril 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 Amoli Organics (a Division Of Umedica Laboratories Pvt. Ltd.) on September 01, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to treat certain types of heart failure. It may help you live longer and lower your chance of having to go to the hospital for heart failure. This product contains 2 medications: sacubitril and valsartan. Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). They work by relaxing blood vessels so that blood can flow more easily, which makes it easier for your heart to pump blood to your body.

How is this Amoli Organics (a Division Of Umedica Laboratories Pvt. Ltd.) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62512008500. 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)
62512-0085-0
11-Digit CMS (5-4-2)
62512-0085-00

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