Aminocaproic Acid Tablet
NDC Package 80005-128-08

11-digit billing NDC: 80005012808
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Aminocaproic Acid tablets is aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. This formulation utilizes a tablet delivery system. Marketed by Carnegie Pharmaceuticals, Llc, this product is identified by NDC 80005-128 and is authorized under FDA application ANDA213928.

Identification & Billing

NDC Package Code
80005-128-08
Package Description
30 TABLET in 1 BOTTLE
Product Code
80005-128
11-Digit Billing Format
80005012808
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 500 mg/1
Pharmacologic Class
Usage Information
Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life- threatening situations, transfusion of appropriate blood products and other emergency measures may be required.Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.)

Regulatory & Marketing

Labeler Name
Carnegie Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213928
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-15-2021
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 80005-128-08 identifies a specific commercial package of 30 tablet in 1 bottle of Aminocaproic Acid, a human prescription drug labeled by Carnegie Pharmaceuticals, Llc. 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 Carnegie Pharmaceuticals, Llc on March 15, 2021. The current certification is valid through December 31, 2026.

How is this Carnegie Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80005012808. 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)
80005-128-08
11-Digit CMS (5-4-2)
80005-0128-08

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