Ella
NDC Package 50102-911-01
Package Information
Ella is ulipristal is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. Marketed by Afaxys Pharma Llc, this product is identified by NDC 50102-911 and is authorized under FDA application NDA022474.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50102 - Afaxys Pharma Llc
- 50102-911 - Ella
- 50102-911-01 - 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
- 50102-911 - Ella
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 the distribution configuration for this product package?
The code 50102-911-01 identifies a specific commercial package of 1 blister pack in 1 carton / 1 tablet in 1 blister pack of Ella, labeled by Afaxys Pharma Llc. 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 Afaxys Pharma Llc on August 13, 2010. The current certification is valid through May 15, 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 Afaxys Pharma Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50102091101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.