Pregnyl
NDC Package 54868-4997-0

11-digit billing NDC: 54868499700 · Billing unit: EA · 1 EA per package
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 hCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. 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.
Units Per Package
1 EA
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
HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.Prepubertal cryptorchidism not due to anatomical obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases, the response is temporary. Therapy is usually instituted in children between the ages of 4 and 9.Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

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 product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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.

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.. There are 1 total billable units per package. 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.