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  5. NDC Package Code: 69238-1521-3 Norelgestromin And Ethinly Estradiol

NDC Package 69238-1521-3 Norelgestromin And Ethinly Estradiol

Patch Transdermal - 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:
69238-1521-3
Package Description:
3 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (69238-1521-1) / 7 d in 1 PATCH
Product Code:
69238-1521
Proprietary Name:
Norelgestromin And Ethinly Estradiol
Non-Proprietary Name:
Norelgestromin And Ethinly Estradiol
Substance Name:
Ethinyl Estradiol; Norelgestromin
Usage Information:
Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].
11-Digit NDC Billing Format:
69238152103
NDC to RxNorm Crosswalk:
  • RxCUI: 1534809 - norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System
  • RxCUI: 1534809 - 168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System
  • RxCUI: 1534809 - ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR 7 Day Transdermal Patch
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Ny Llc
    Dosage Form:
    Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
    Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • ETHINYL ESTRADIOL 35 ug/d
  • NORELGESTROMIN 150 ug/d
    • Pharmacologic Class(es):
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213950
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-26-2021
    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 69238-1521-3?

    The NDC Packaged Code 69238-1521-3 is assigned to a package of 3 pouch in 1 carton / 1 patch in 1 pouch (69238-1521-1) / 7 d in 1 patch of Norelgestromin And Ethinly Estradiol, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is patch and is administered via transdermal form.

    Is NDC 69238-1521 included in the NDC Directory?

    Yes, Norelgestromin And Ethinly Estradiol with product code 69238-1521 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Ny Llc on February 26, 2021 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 69238-1521-3?

    The 11-digit format is 69238152103. 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
    5-4-169238-1521-35-4-269238-1521-03