NDC Package 53183-4037-1 Ulipristal Acetate

Powder - View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53183-4037-1
Package Description:
1 kg in 1 CARTON
Product Code:
Non-Proprietary Name:
Ulipristal Acetate
Substance Name:
Ulipristal Acetate
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).
11-Digit NDC Billing Format:
53183403701
Product Type:
Bulk Ingredient
Labeler Name:
Sicor S.r.l.
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):
Sample Package:
N/A
Marketing Category:
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date:
07-12-2013
Listing Expiration Date:
12-31-2024
Exclude Flag:
N
Unfinished Product:
Yes
Code Structure:

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.

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Frequently Asked Questions

What is NDC 53183-4037-1?

The NDC Packaged Code 53183-4037-1 is assigned to an UNFINISHED drug package of 1 kg in 1 carton of Ulipristal Acetate, a bulk ingredient labeled by Sicor S.r.l.. The product's dosage form is powder and is administered via form.

Is NDC 53183-4037 included in the NDC Directory?

Yes, Ulipristal Acetate is an UNFINISHED PRODUCT with code 53183-4037 that is active and included in the NDC Directory. The product was first marketed by Sicor S.r.l. on July 12, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53183-4037-1?

The 11-digit format is 53183403701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-153183-4037-15-4-253183-4037-01