Ella
NDC Package 53002-1630-1

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 inactivated by the FDA.

Ella is ulipristal is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1630 and is authorized under FDA application NDA022474.

Identification & Billing

NDC Package Code
53002-1630-1
Package Description
1 TABLET in 1 DOSE PACK
Product Code
53002-1630
11-Digit Billing Format
53002163001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ella
Dosage Form
-
Usage Information
Ulipristal is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This medication is an emergency contraceptive and should not be used as a regular form of birth control. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Using this medication will not stop an existing pregnancy or protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia). This medication may not work well in women who are overweight (for example, body mass index greater than 30) or if you are using certain other medications. This effect can result in pregnancy. Talk to your doctor for more details and to see if this medication is right for you (see also Drug Interactions section).

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
NDA022474
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-13-2010
Listing Expiration
12-31-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53002-1630-1 identifies a specific commercial package of 1 tablet in 1 dose pack of Ella, labeled by Rpk Pharmaceuticals, 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 Rpk Pharmaceuticals, Inc. on August 13, 2010. The current certification is valid through December 31, 2022.

What are the primary indications for this medication?

Ulipristal is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This medication is an emergency contraceptive and should not be used as a regular form of birth control. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Using this medication will not stop an existing pregnancy or protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia). This medication may not work well in women who are overweight (for example, body mass index greater than 30) or if you are using certain other medications. This effect can result in pregnancy. Talk to your doctor for more details and to see if this medication is right for you (see also Drug Interactions section).

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002163001. 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)
53002-1630-1
11-Digit CMS (5-4-2)
53002-1630-01

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