Hydroxyprogesterone Caproate
NDC Package 62559-540-55

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Hydroxyprogesterone Caproate 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 Ani Pharmaceuticals, Inc., this product is identified by NDC 62559-540 and is authorized under FDA application ANDA200271.

Identification & Billing

NDC Package Code
62559-540-55
Package Description
5 VIAL, GLASS in 1 TRAY / 5 mL in 1 VIAL, GLASS
Product Code
62559-540
11-Digit Billing Format
62559054055

Clinical Specifications

Proprietary Name
Hydroxyprogesterone Caproate
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
Ani Pharmaceuticals, Inc.
FDA Application #
ANDA200271
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-03-2016
End Marketing Date
07-31-2018
Listing Expiration
07-31-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62559-540). Click a package code to view its specific billing and regulatory data.

62559-540-15
1 VIAL, GLASS in 1 PACKAGE / 5 mL in 1 VIAL, GLASS

* 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 62559-540-55 identifies a specific commercial package of 5 vial, glass in 1 tray / 5 ml in 1 vial, glass of Hydroxyprogesterone Caproate, labeled by Ani 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 Ani Pharmaceuticals, Inc. on June 03, 2016. The current certification is valid through July 31, 2018.

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 Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62559054055. 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)
62559-540-55
11-Digit CMS (5-4-2)
62559-0540-55

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