NDC Package 60846-232-01 Activella

Estradiol/norethindrone Acetate Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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:
60846-232-01
Package Description:
1 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
Proprietary Name:
Activella
Non-Proprietary Name:
Estradiol/norethindrone Acetate
Substance Name:
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:
60846023201
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1359123 - estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet
  • RxCUI: 1359124 - {28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack
  • RxCUI: 1359124 - Estra-Noreth Ac 0.5-0.1 MG (28) Oral Tablet 28 Day Pack
  • RxCUI: 1359125 - {28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Activella 0.5/0.1 28 Day]
  • RxCUI: 1359125 - Activella 0.5/0.1 28 Day Pack
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    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.
  • Sample Package:
    No
    FDA Application Number:
    NDA020907
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-01-2019
    Listing Expiration Date:
    12-31-2025
    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 60846-232-01?

    The NDC Packaged Code 60846-232-01 is assigned to a package of 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack of Activella, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 60846-232 included in the NDC Directory?

    Yes, Activella with product code 60846-232 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on May 01, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 60846-232-01?

    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 1.

    What is the 11-digit format for NDC 60846-232-01?

    The 11-digit format is 60846023201. 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
    5-3-260846-232-015-4-260846-0232-01