Clomid Tablet
NDC Package 0713-0885-30

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

Clomid (clomiphene citrate) tablets is a medication used to treat infertility in women. This formulation utilizes a tablet delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0885 and is authorized under FDA application ANDA075528.

Identification & Billing

NDC Package Code
0713-0885-30
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
0713-0885
11-Digit Billing Format
00713088530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clomid
Non-Proprietary Name
Clomiphene Citrate
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
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075528
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-09-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0713-0885). Click a package code to view its specific billing and regulatory data.

0713-0885-09
1 BLISTER PACK in 1 CARTON / 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 0713-0885-30 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet in 1 blister pack of Clomid, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. 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 Cosette Pharmaceuticals, Inc. on September 09, 2022. 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 Cosette Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713088530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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:

10-Digit Format (4-4-2)
0713-0885-30
11-Digit CMS (5-4-2)
00713-0885-30

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