Hydrochlorothiazide
NDC Package 12634-445-91

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Hydrochlorothiazide is a medication used to treat high blood pressure. Marketed by Apotheca, Inc., this product is identified by NDC 12634-445 and is authorized under FDA application ANDA084325.

Identification & Billing

NDC Package Code
12634-445-91
Package Description
1 TABLET in 1 BLISTER PACK
Product Code
12634-445
11-Digit Billing Format
12634044591
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydrochlorothiazide
Dosage Form
-
Usage Information
This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Hydrochlorothiazide belongs to a class of drugs known as diuretics/"water pills." It works by causing you to make more urine. This helps your body get rid of extra salt and water. This medication also reduces extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, or kidney disease. This can lessen symptoms such as shortness of breath or swelling in your ankles or feet.

Regulatory & Marketing

Labeler Name
Apotheca, Inc.
FDA Application #
ANDA084325
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-21-1996
Listing Expiration
12-31-2017
Exclude Flag
I
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 (12634-445). Click a package code to view its specific billing and regulatory data.

12634-445-50
50 TABLET in 1 BOTTLE
12634-445-60
60 TABLET in 1 BOTTLE
12634-445-71
30 TABLET in 1 BOTTLE
12634-445-78
28 TABLET in 1 BOTTLE
12634-445-79
25 TABLET in 1 BOTTLE
12634-445-85
15 TABLET in 1 BOTTLE
12634-445-90
90 TABLET in 1 BOTTLE

* 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 12634-445-91 identifies a specific commercial package of 1 tablet in 1 blister pack of Hydrochlorothiazide, labeled by Apotheca, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Apotheca, Inc. on December 21, 1996. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Hydrochlorothiazide belongs to a class of drugs known as diuretics/"water pills." It works by causing you to make more urine. This helps your body get rid of extra salt and water. This medication also reduces extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, or kidney disease. This can lessen symptoms such as shortness of breath or swelling in your ankles or feet.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634044591. 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)
12634-445-91
11-Digit CMS (5-4-2)
12634-0445-91

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