Clomiphene Citrate Tablet
NDC Package 55801-187-01

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

Package Information

Clomiphene Citrate (clomiphene citrtae) tablets is a medication used to treat infertility in women. This formulation utilizes a tablet delivery system. Marketed by Appco Pharma Llc, this product is identified by NDC 55801-187 and is authorized under FDA application ANDA216739.

Identification & Billing

NDC Package Code
55801-187-01
Package Description
30 TABLET in 1 BOTTLE
Product Code
55801-187
11-Digit Billing Format
55801018701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clomiphene Citrate
Non-Proprietary Name
Clomiphene Citrtae
Substance Name
Clomiphene Citrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLOMIPHENE CITRATE 50 mg/1
Pharmacologic Class
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
Appco Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216739
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-18-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 55801-187-01 identifies a specific commercial package of 30 tablet in 1 bottle of Clomiphene Citrate, a human prescription drug labeled by Appco Pharma Llc. This tablet is formulated for oral use and contains clomiphene citrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Appco Pharma Llc on November 18, 2024. The current certification is valid through December 31, 2026.

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 Appco Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55801018701. 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 (5-3-2)
55801-187-01
11-Digit CMS (5-4-2)
55801-0187-01

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