Makena
NDC Package 64011-243-01

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.

Makena is a medication used in women who are pregnant with a single baby, and who have delivered a baby too early (preterm) in the past. Marketed by Amag Pharmaceuticals, Inc., this product is identified by NDC 64011-243 and is authorized under FDA application NDA021945.

Identification & Billing

NDC Package Code
64011-243-01
Package Description
1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS
Product Code
64011-243
11-Digit Billing Format
64011024301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Makena
Dosage Form
-
Usage Information
This medication is used in women who are pregnant with a single baby, and who have delivered a baby too early (preterm) in the past. It is used to help lower the risk of having a preterm baby again. Hydroxyprogesterone is a man-made form of a female hormone (progestin). It is not known how it works to prevent preterm births. This medication is not intended to prevent preterm birth in women pregnant with more than one baby (such as twins, triplets). It is also not intended to stop active preterm labor.

Regulatory & Marketing

Labeler Name
Amag Pharmaceuticals, Inc.
FDA Application #
NDA021945
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-03-2011
End Marketing Date
10-02-2023
Listing Expiration
10-02-2023
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 64011-243-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 5 ml in 1 vial, glass of Makena, labeled by Amag Pharmaceuticals, 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 Amag Pharmaceuticals, Inc. on February 03, 2011. The current certification is valid through October 02, 2023.

What are the primary indications for this medication?

This medication is used in women who are pregnant with a single baby, and who have delivered a baby too early (preterm) in the past. It is used to help lower the risk of having a preterm baby again. Hydroxyprogesterone is a man-made form of a female hormone (progestin). It is not known how it works to prevent preterm births. This medication is not intended to prevent preterm birth in women pregnant with more than one baby (such as twins, triplets). It is also not intended to stop active preterm labor.

How is this Amag Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64011024301. 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 (5-3-2)
64011-243-01
11-Digit CMS (5-4-2)
64011-0243-01

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