Progesterone
NDC Package 54868-3396-0

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 discontinued by the firm.

Progesterone is a type of female hormone (progestin). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3396 and is authorized under FDA application NDA017362.

Identification & Billing

NDC Package Code
54868-3396-0
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
54868-3396
11-Digit Billing Format
54868339600

Clinical Specifications

Proprietary Name
Progesterone
Dosage Form
-
Usage Information
Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA017362
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-15-1998
End Marketing Date
10-31-2004
Listing Expiration
10-31-2004
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 54868-3396-0 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Progesterone, 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 October 15, 1998. The current certification is valid through October 31, 2004.

What are the primary indications for this medication?

Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.

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: 54868339600. 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)
54868-3396-0
11-Digit CMS (5-4-2)
54868-3396-00

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