Aminocaproic Acid
NDC Package 52584-346-16

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Aminocaproic Acid is a medication used to help control bleeding due to a condition where your blood does not clot the way it normally should (fibrinolysis). Marketed by General Injectables And Vaccines, Inc., this product is identified by NDC 52584-346 and is authorized under FDA application ANDA070010.

Identification & Billing

NDC Package Code
52584-346-16
Package Description
1 VIAL, SINGLE-DOSE in 1 BAG / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code
52584-346
11-Digit Billing Format
52584034616

Clinical Specifications

Proprietary Name
Aminocaproic Acid
Dosage Form
-
Usage Information
This medication is used to help control bleeding due to a condition where your blood does not clot the way it normally should (fibrinolysis). This may cause serious bleeding after certain surgeries or in certain conditions (such as bleeding disorders, liver disease, cancer). Aminocaproic acid works by helping your blood clot normally. It belongs to a class of drugs known as antifibrinolytics.

Regulatory & Marketing

Labeler Name
General Injectables And Vaccines, Inc.
FDA Application #
ANDA070010
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-02-2018
End Marketing Date
04-01-2023
Listing Expiration
04-01-2023
Exclude Flag
D
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 52584-346-16 identifies a specific commercial package of 1 vial, single-dose in 1 bag / 20 ml in 1 vial, single-dose of Aminocaproic Acid, labeled by General Injectables And Vaccines, 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 General Injectables And Vaccines, Inc. on July 02, 2018. The current certification is valid through April 01, 2023.

What are the primary indications for this medication?

This medication is used to help control bleeding due to a condition where your blood does not clot the way it normally should (fibrinolysis). This may cause serious bleeding after certain surgeries or in certain conditions (such as bleeding disorders, liver disease, cancer). Aminocaproic acid works by helping your blood clot normally. It belongs to a class of drugs known as antifibrinolytics.

How is this General Injectables And Vaccines, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52584034616. 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)
52584-346-16
11-Digit CMS (5-4-2)
52584-0346-16

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