Cyklokapron Injection, Solution
NDC Package 0013-1114-10

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

Cyklokapron (tranexamic acid) injection is a medication used to treat heavy bleeding during your menstrual period. This formulation utilizes a injection, solution delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0013-1114 and is authorized under FDA application NDA019281.

Identification & Billing

NDC Package Code
0013-1114-10
Package Description
10 CARTON in 1 BOX / 1 AMPULE in 1 CARTON / 10 mL in 1 AMPULE (0013-1114-01)
Product Code
0013-1114
11-Digit Billing Format
00013111410
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyklokapron
Non-Proprietary Name
Tranexamic Acid
Substance Name
Tranexamic Acid
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TRANEXAMIC ACID 100 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat heavy bleeding during your menstrual period. Tranexamic acid works by slowing the breakdown of blood clots, which helps to prevent prolonged bleeding. It belongs to a class of drugs known as antifibrinolytics. Tranexamic acid is not a hormone. It does not treat other menstrual or pre-menstrual symptoms. It does not stop your period. It is not a form of birth control and does not protect against sexually transmitted diseases.

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
NDA019281
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-30-1986
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 (0013-1114). Click a package code to view its specific billing and regulatory data.

0013-1114-15
1 AMPULE in 1 CARTON / 10 mL in 1 AMPULE (0013-1114-01)
0013-1114-21
10 VIAL in 1 BOX / 10 mL in 1 VIAL (0013-1114-20)

* 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 0013-1114-10 identifies a specific commercial package of 10 carton in 1 box / 1 ampule in 1 carton / 10 ml in 1 ampule (0013-1114-01) of Cyklokapron, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This injection, solution is formulated for intravenous use and contains tranexamic 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 Pfizer Laboratories Div Pfizer Inc on December 30, 1986. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat heavy bleeding during your menstrual period. Tranexamic acid works by slowing the breakdown of blood clots, which helps to prevent prolonged bleeding. It belongs to a class of drugs known as antifibrinolytics. Tranexamic acid is not a hormone. It does not treat other menstrual or pre-menstrual symptoms. It does not stop your period. It is not a form of birth control and does not protect against sexually transmitted diseases.

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00013111410. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0013-1114-10
11-Digit CMS (5-4-2)
00013-1114-10

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