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  5. NDC Package Code: 53002-1600-1 Azurette

NDC Package 53002-1600-1 Azurette

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
53002-1600-1
Package Description:
1 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
Product Code:
53002-1600
Proprietary Name:
Azurette
Usage Information:
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin (desogestrel) and an estrogen (ethinyl estradiol). 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. If a fertilized egg does not attach to the uterus, it passes out of the body. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
11-Digit NDC Billing Format:
53002160001
NDC to RxNorm Crosswalk:
  • RxCUI: 248310 - ethinyl estradiol 0.01 MG Oral Tablet
  • RxCUI: 248310 - ethinyl estradiol 10 MCG Oral Tablet
  • RxCUI: 249357 - desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
    • Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Sample Package:
    No
    Start Marketing Date:
    11-14-2016
    Listing Expiration Date:
    12-31-2022
    Exclude Flag:
    I
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53002-1600-33 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
    53002-1600-66 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-1600-1?

    The NDC Packaged Code 53002-1600-1 is assigned to a package of 1 blister pack in 1 package / 1 kit in 1 blister pack of Azurette, labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

    Is NDC 53002-1600 included in the NDC Directory?

    No, Azurette with product code 53002-1600 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rpk Pharmaceuticals, Inc. on November 14, 2016 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53002-1600-1?

    The 11-digit format is 53002160001. 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
    5-4-153002-1600-15-4-253002-1600-01