Spironolactone And Hydrochlorothiazide Tablet
NDC Package 53489-144-01

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

Spironolactone And Hydrochlorothiazide tablets is spironolactone, an ingredient of spironolactone and hydrochlorothiazide, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). This formulation utilizes a tablet delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 53489-144 and is authorized under FDA application ANDA089534.

Identification & Billing

NDC Package Code
53489-144-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
53489-144
11-Digit Billing Format
53489014401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 198224 - spironolactone 25 MG / hydroCHLOROthiazide 25 MG Oral Tablet
  • RxCUI: 198224 - hydrochlorothiazide 25 MG / spironolactone 25 MG Oral Tablet
  • RxCUI: 198224 - HCTZ 25 MG / spironolactone 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Spironolactone And Hydrochlorothiazide
Non-Proprietary Name
Spironolactone And Hydrochlorothiazide
Substance Name
Hydrochlorothiazide; Spironolactone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Spironolactone, an ingredient of spironolactone and hydrochlorothiazide, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide should be used only in those conditions described below. Unnecessary use of this drug should be avoided.Spironolactone and hydrochlorothiazide is indicated for:Edematous conditions for patients with:

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA089534
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-02-1987
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 (53489-144). Click a package code to view its specific billing and regulatory data.

53489-144-05
500 TABLET in 1 BOTTLE, PLASTIC
53489-144-10
1000 TABLET 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 53489-144-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Spironolactone And Hydrochlorothiazide, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet is formulated for oral use and contains hydrochlorothiazide; 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 Sun Pharmaceutical Industries, Inc. on July 02, 1987. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53489014401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
53489-144-01
11-Digit CMS (5-4-2)
53489-0144-01

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