Aminocaproic Acid Tablet
NDC Package 69680-116-30

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

Aminocaproic Acid tablets is a medication used to help control bleeding due to a condition where your blood does not clot the way it normally should (fibrinolysis). This formulation utilizes a tablet delivery system. Marketed by Vitruvias Therapeutics, this product is identified by NDC 69680-116 and is authorized under FDA application ANDA209060.

Identification & Billing

NDC Package Code
69680-116-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
69680-116
11-Digit Billing Format
69680011630
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Aminocaproic Acid
Non-Proprietary Name
Aminocaproic Acid
Substance Name
Aminocaproic Acid
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)
AMINOCAPROIC ACID 1000 mg/1
Pharmacologic Class
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
Vitruvias Therapeutics
Product Type
Human Prescription Drug
FDA Application #
ANDA209060
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-03-2018
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 (69680-116). Click a package code to view its specific billing and regulatory data.

69680-116-00
100 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 69680-116-30 identifies a specific commercial package of 30 tablet in 1 bottle of Aminocaproic Acid, a human prescription drug labeled by Vitruvias Therapeutics. This tablet is formulated for oral use and contains aminocaproic acid 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 Vitruvias Therapeutics on December 03, 2018. The current certification is valid through December 31, 2026.

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 Vitruvias Therapeutics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69680011630. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
69680-116-30
11-Digit CMS (5-4-2)
69680-0116-30

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