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  5. NDC Package Code: 53002-2630-1 Ella

NDC Package 53002-2630-1 Ella

Ulipristal Acetate Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
53002-2630-1
Package Description:
1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code:
53002-2630
Proprietary Name:
Ella
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:
53002263001
NDC to RxNorm Crosswalk:
  • RxCUI: 1005924 - ulipristal acetate 30 MG Oral Tablet
  • RxCUI: 1005928 - Ella 30 MG Oral Tablet
  • RxCUI: 1005928 - ulipristal acetate 30 MG Oral Tablet [Ella]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ULIPRISTAL ACETATE 30 mg/1
    • Pharmacologic Class(es):
  • Progesterone Agonist/Antagonist - [EPC] (Established Pharmacologic Class)
  • Selective Progesterone Receptor Modulators - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA022474
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-11-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-2630-1?

    The NDC Packaged Code 53002-2630-1 is assigned to a package of 1 blister pack in 1 carton / 1 tablet in 1 blister pack of Ella, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 53002-2630 included in the NDC Directory?

    Yes, Ella with product code 53002-2630 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on May 11, 2020 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 53002-2630-1?

    The 11-digit format is 53002263001. 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
    5-4-153002-2630-15-4-253002-2630-01