Prometrium
NDC Package 54868-4230-2
Package Information
Prometrium is progesterone is a type of female hormone (progestin). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4230 and is authorized under FDA application NDA019781.
Identification & Billing
- RxCUI: 260243 - progesterone 100 MG Oral Capsule
- RxCUI: 261319 - Prometrium 200 MG Oral Capsule
- RxCUI: 261319 - progesterone 200 MG Oral Capsule [Prometrium]
- RxCUI: 262080 - Prometrium 100 MG Oral Capsule
- RxCUI: 262080 - progesterone 100 MG Oral Capsule [Prometrium]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-4230 - Prometrium
- 54868-4230-2 - 5 CAPSULE in 1 BOTTLE
- 54868-4230 - Prometrium
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 (54868-4230). Click a package code to view its specific billing and regulatory data.
* 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 54868-4230-2 identifies a specific commercial package of 5 capsule in 1 bottle of Prometrium, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 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 November 03, 2004. The current certification is valid through December 31, 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 Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868423002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
