Spironolactone Powder
NDC Package 61907-031-20

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

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.

Spironolactone powders is spironolactone is used to treat high blood pressure and heart failure. This formulation utilizes a powder delivery system. Marketed by Tianjin Jinjin Pharmaceutical Co.,ltd, this product is identified by NDC 61907-031.

Identification & Billing

NDC Package Code
61907-031-20
Package Description
20 kg in 1 DRUM
Product Code
61907-031
11-Digit Billing Format
61907003120

Clinical Specifications

Proprietary Name
Spironolactone
Non-Proprietary Name
Spironolactone
Substance Name
Spironolactone
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)
SPIRONOLACTONE 1 kg/kg
Usage Information
Spironolactone is used to treat high blood pressure and heart failure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat swelling (edema) caused by certain conditions (such as heart failure, liver disease) by removing excess fluid and improving symptoms such as breathing problems. This medication is also used to treat conditions in which the body is making too much of a natural substance (aldosterone). Spironolactone is known as a "water pill" (potassium-sparing diuretic).

Regulatory & Marketing

Labeler Name
Tianjin Jinjin Pharmaceutical Co.,ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
07-14-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61907-031). Click a package code to view its specific billing and regulatory data.

61907-031-05
5 kg in 1 CARTON
61907-031-10
10 kg in 1 CARTON
61907-031-25
25 kg in 1 DRUM
61907-031-99
.5 kg in 1 PACKAGE, COMBINATION

* 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 61907-031-20 identifies a specific commercial package of 20 kg in 1 drum of Spironolactone (UNFINISHED drug), a bulk ingredient labeled by Tianjin Jinjin Pharmaceutical Co.,ltd. This powder is formulated for use and contains spironolactone 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 Tianjin Jinjin Pharmaceutical Co.,ltd on July 14, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Spironolactone is used to treat high blood pressure and heart failure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat swelling (edema) caused by certain conditions (such as heart failure, liver disease) by removing excess fluid and improving symptoms such as breathing problems. This medication is also used to treat conditions in which the body is making too much of a natural substance (aldosterone). Spironolactone is known as a "water pill" (potassium-sparing diuretic).

How is this Tianjin Jinjin Pharmaceutical Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61907003120. 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)
61907-031-20
11-Digit CMS (5-4-2)
61907-0031-20

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