Hydroxyprogesterone Caproate Injection
NDC Package 18124-016-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Hydroxyprogesterone Caproate injection 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. This formulation utilizes a injection delivery system. Marketed by Fresenius Kabi Austria Gmbh, this product is identified by NDC 18124-016.

Identification & Billing

NDC Package Code
18124-016-01
Package Description
1 SYRINGE in 1 CARTON / 1.1 mL in 1 SYRINGE
Product Code
18124-016
11-Digit Billing Format
18124001601

Clinical Specifications

Proprietary Name
Hydroxyprogesterone Caproate
Non-Proprietary Name
Hydroxyprogesterone Caproate
Substance Name
Hydroxyprogesterone Caproate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
HYDROXYPROGESTERONE CAPROATE 250 mg/mL
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
Fresenius Kabi Austria Gmbh
Product Type
Human Prescription Drug
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
02-03-2011
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 18124-016-01 identifies a specific commercial package of 1 syringe in 1 carton / 1.1 ml in 1 syringe of Hydroxyprogesterone Caproate (UNFINISHED drug), a human prescription drug labeled by Fresenius Kabi Austria Gmbh. This injection is formulated for use and contains hydroxyprogesterone caproate 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 Fresenius Kabi Austria Gmbh on February 03, 2011. The current certification is valid through December 31, 2026.

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 Fresenius Kabi Austria Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 18124001601. 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)
18124-016-01
11-Digit CMS (5-4-2)
18124-0016-01

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