Captopril
NDC Package 57721-904-02

11-digit billing NDC: 57721090402
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.

Captopril is hypertension: Captopril tablets, USP are indicated for the treatment of hypertension.In using captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. Marketed by Windlas Biotech Limited, this product is identified by NDC 57721-904 and is authorized under FDA application ANDA074532.

Identification & Billing

NDC Package Code
57721-904-02
Package Description
1000 TABLET in 1 BOTTLE
Product Code
57721-904
11-Digit Billing Format
57721090402
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Captopril
Dosage Form
-
Usage Information
Hypertension: Captopril tablets, USP are indicated for the treatment of hypertension.In using captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).Captopril may be used as initial therapy 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 should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.Captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.Heart Failure: Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment.Left Ventricular Dysfunction After Myocardial Infarction: Captopril tablets are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.Diabetic Nephropathy: Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).In considering use of captopril tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).

Regulatory & Marketing

Labeler Name
Windlas Biotech Limited
FDA Application #
ANDA074532
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-28-1997
Listing Expiration
12-31-2022
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 (57721-904). Click a package code to view its specific billing and regulatory data.

57721-904-01
100 TABLET in 1 BOTTLE
57721-904-05
5000 TABLET in 1 POUCH

* 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 57721-904-02 identifies a specific commercial package of 1000 tablet in 1 bottle of Captopril, labeled by Windlas Biotech Limited. 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 Windlas Biotech Limited on March 28, 1997. The current certification is valid through December 31, 2022.

How is this Windlas Biotech Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57721090402. 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)
57721-904-02
11-Digit CMS (5-4-2)
57721-0904-02

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