Ulipristal Acetate Powder
NDC Package 53183-4037-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ulipristal Acetate powders is ulipristal is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This formulation utilizes a powder delivery system. Marketed by Sicor S.r.l., this product is identified by NDC 53183-4037.

Identification & Billing

NDC Package Code
53183-4037-1
Package Description
1 kg in 1 CARTON
Product Code
53183-4037
11-Digit Billing Format
53183403701

Clinical Specifications

Proprietary Name
Ulipristal Acetate
Non-Proprietary Name
Ulipristal Acetate
Substance Name
Ulipristal Acetate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ULIPRISTAL ACETATE 100 kg/100kg
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
Sicor S.r.l.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-12-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 53183-4037-1 identifies a specific commercial package of 1 kg in 1 carton of Ulipristal Acetate (UNFINISHED drug), a bulk ingredient labeled by Sicor S.r.l.. This powder is formulated for use and contains ulipristal acetate 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 Sicor S.r.l. on July 12, 2013. The current certification is valid through December 31, 2026.

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 Sicor S.r.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53183403701. 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)
53183-4037-1
11-Digit CMS (5-4-2)
53183-4037-01

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