Captopril And Hydrochlorothiazide Tablet
NDC Package 16571-830-09

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

Package Information

Captopril And Hydrochlorothiazide tablets are indicated for the treatment of hypertension. This formulation utilizes a tablet delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 16571-830 and is authorized under FDA application ANDA074896.

Identification & Billing

NDC Package Code
16571-830-09
Package Description
90 TABLET in 1 BOTTLE
Product Code
16571-830
11-Digit Billing Format
16571083009
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
  • RxCUI: 197436 - captopril 25 MG / hydroCHLOROthiazide 15 MG Oral Tablet
  • RxCUI: 197436 - captopril 25 MG / hydrochlorothiazide 15 MG Oral Tablet
  • RxCUI: 197436 - captopril 25 MG / HCTZ 15 MG Oral Tablet
  • RxCUI: 197437 - captopril 25 MG / hydroCHLOROthiazide 25 MG Oral Tablet
  • RxCUI: 197437 - captopril 25 MG / hydrochlorothiazide 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Captopril And Hydrochlorothiazide
Non-Proprietary Name
Captopril And Hydrochlorothiazide
Substance Name
Captopril; Hydrochlorothiazide
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
Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components. When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate. Treatment may, therefore, be initiated with captopril and hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as captopril and hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see DOSAGE AND ADMINISTRATION).In using captopril and hydrochlorothiazide, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).Captopril and hydrochlorothiazide may be used for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril and hydrochlorothiazide should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to other drug combinations.ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Captopril: Head and Neck Angioedema and Intestinal Angioedema).

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA074896
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 16571-830-09 identifies a specific commercial package of 90 tablet in 1 bottle of Captopril And Hydrochlorothiazide, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet is formulated for oral use and contains captopril; hydrochlorothiazide 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 Rising Pharma Holdings, Inc. on February 14, 2023. The current certification is valid through December 31, 2026.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16571083009. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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)
16571-830-09
11-Digit CMS (5-4-2)
16571-0830-09

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