Prometrium
NDC Package 69189-1708-1

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.

Prometrium is progesterone is a type of female hormone (progestin). Marketed by Avera Mckennan Hospital, this product is identified by NDC 69189-1708 and is authorized under FDA application NDA019781.

Identification & Billing

NDC Package Code
69189-1708-1
Package Description
1 CAPSULE in 1 DOSE PACK
Product Code
69189-1708
11-Digit Billing Format
69189170801

Clinical Specifications

Proprietary Name
Prometrium
Dosage Form
-
Usage Information
Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and not going through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). Progesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Progesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. This medication is not for use in children. Progesterone must not be used to test for pregnancy.

Regulatory & Marketing

Labeler Name
Avera Mckennan Hospital
FDA Application #
NDA019781
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-11-2015
End Marketing Date
05-24-2017
Listing Expiration
05-24-2017
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 69189-1708-1 identifies a specific commercial package of 1 capsule in 1 dose pack of Prometrium, labeled by Avera Mckennan Hospital. 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 Avera Mckennan Hospital on August 11, 2015. The current certification is valid through May 24, 2017.

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 and is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and not going through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). Progesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Progesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. This medication is not for use in children. Progesterone must not be used to test for pregnancy.

How is this Avera Mckennan Hospital product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69189170801. 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)
69189-1708-1
11-Digit CMS (5-4-2)
69189-1708-01

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