Clomiphene Citrate
NDC Package 54868-3059-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Clomiphene Citrate is a medication used to treat infertility in women. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3059 and is authorized under FDA application ANDA075528.

Identification & Billing

NDC Package Code
54868-3059-2
Package Description
30 TABLET in 1 BOTTLE
Product Code
54868-3059
11-Digit Billing Format
54868305902
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clomiphene Citrate
Dosage Form
-
Usage Information
This medication is used to treat infertility in women. It works by stimulating an increase in the amount of hormones that support the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary pituitary or ovarian failure).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA075528
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-22-1996
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-3059). Click a package code to view its specific billing and regulatory data.

54868-3059-0
1 BLISTER PACK in 1 BOTTLE, DISPENSING / 5 TABLET in 1 BLISTER PACK
54868-3059-1
1 BLISTER PACK in 1 BOTTLE, DISPENSING / 10 TABLET in 1 BLISTER PACK

* 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 54868-3059-2 identifies a specific commercial package of 30 tablet in 1 bottle of Clomiphene Citrate, 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 22, 1996. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat infertility in women. It works by stimulating an increase in the amount of hormones that support the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary pituitary or ovarian failure).

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: 54868305902. 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)
54868-3059-2
11-Digit CMS (5-4-2)
54868-3059-02

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