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  5. NDC Package Code: 68180-827-09 Fyavolv

NDC Package 68180-827-09 Fyavolv

Norethindrone Acetate And Ethinyl Estradiol Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
68180-827-09
Package Description:
90 TABLET, FILM COATED in 1 BOTTLE
Product Code:
68180-827
Proprietary Name:
Fyavolv
Non-Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol
Substance Name:
Ethinyl Estradiol; Norethindrone Acetate
Usage Information:
This medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. The progestin in this medication helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen/progestin treatment.
11-Digit NDC Billing Format:
68180082709
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1090992 - norethindrone acetate 1 MG / ethinyl estradiol 5 MCG Oral Tablet
  • RxCUI: 1090992 - ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1090992 - ethinyl estradiol 5 MCG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1251323 - norethindrone acetate 0.5 MG / ethinyl estradiol 2.5 MCG Oral Tablet
  • RxCUI: 1251323 - ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ETHINYL ESTRADIOL .0025 mg/1
  • NORETHINDRONE ACETATE .5 mg/1
    • 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:
    ANDA204213
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-15-2016
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68180-827-733 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68180-827-09?

    The NDC Packaged Code 68180-827-09 is assigned to a package of 90 tablet, film coated in 1 bottle of Fyavolv, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 68180-827 included in the NDC Directory?

    Yes, Fyavolv with product code 68180-827 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals, Inc. on March 15, 2016 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 NDC billing unit for package 68180-827-09?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 90.

    What is the 11-digit format for NDC 68180-827-09?

    The 11-digit format is 68180082709. 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 5-3-2 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
    5-3-268180-827-095-4-268180-0827-09