Pregnyl
NDC Package 54868-4997-0

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 inactivated by the FDA.

Pregnyl is a medication a hormone used in boys (before puberty) to cause the normal dropping of the testicles into the scrotum. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4997 and is authorized under FDA application NDA017692.

Identification & Billing

NDC Package Code
54868-4997-0
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL * 10 mL in 1 VIAL, MULTI-DOSE
Product Code
54868-4997
11-Digit Billing Format
54868499700
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • RxCUI: 896854 - chorionic gonadotropin 10,000 UNT/ML Injectable Solution
  • RxCUI: 896854 - chorionic gonadotropin 10000 UNT/ML Injectable Solution
  • RxCUI: 896856 - Pregnyl 10,000 UNT/ML Injectable Solution
  • RxCUI: 896856 - chorionic gonadotropin 10000 UNT/ML Injectable Solution [Pregnyl]

Clinical Specifications

Proprietary Name
Pregnyl
Dosage Form
-
Usage Information
This medication is a hormone used in boys (before puberty) to cause the normal dropping of the testicles into the scrotum. It is also used in certain boys to help with normal sexual development. It works by causing the testes to release male sex hormones (e.g., testosterone). This medication is also used in women to treat fertility problems. It is given after finishing another medication (menotropins) to cause the release of an egg (ovulation). It should not be used in women whose ovaries no longer make eggs properly (primary ovarian failure). This medication has not been shown to be effective for weight loss and should not be used for this purpose due to risk of serious side effects.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA017692
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-17-2010
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-4997-0 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial * 10 ml in 1 vial, multi-dose of Pregnyl, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on August 17, 2010. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is a hormone used in boys (before puberty) to cause the normal dropping of the testicles into the scrotum. It is also used in certain boys to help with normal sexual development. It works by causing the testes to release male sex hormones (e.g., testosterone). This medication is also used in women to treat fertility problems. It is given after finishing another medication (menotropins) to cause the release of an egg (ovulation). It should not be used in women whose ovaries no longer make eggs properly (primary ovarian failure). This medication has not been shown to be effective for weight loss and should not be used for this purpose due to risk of serious side effects.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868499700. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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 (5-4-1)
54868-4997-0
11-Digit CMS (5-4-2)
54868-4997-00

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