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  5. NDC Package Code: 65162-993-08 Dotti

NDC Package 65162-993-08 Dotti

Estradiol Patch, Extended Release 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:
65162-993-08
Package Description:
8 POUCH in 1 CARTON / 1 d in 1 POUCH (65162-993-04)
Product Code:
65162-993
Proprietary Name:
Dotti
Non-Proprietary Name:
Estradiol
Substance Name:
Estradiol
Usage Information:
This medication is a female hormone (estrogen). 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. 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 who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure). Certain estrogen products 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 treatment.
11-Digit NDC Billing Format:
65162099308
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: 1149632 - estradiol 0.075 MG/Day Twice Weekly Transdermal System
  • RxCUI: 1149632 - 84 HR estradiol 0.00313 MG/HR Transdermal System
  • RxCUI: 1149632 - estradiol 0.00313 MG/HR 84 HR Transdermal Patch
  • RxCUI: 1149632 - estradiol 75 MCG/Day Twice Weekly Transdermal Patch
  • RxCUI: 2110774 - DOTTI 0.025 MG/Day Twice Weekly Transdermal System
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).
    Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • ESTRADIOL .05 mg/d
    • Pharmacologic Class(es):
  • Estradiol Congeners - [CS]
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA211293
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-04-2019
    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 65162-993-08?

    The NDC Packaged Code 65162-993-08 is assigned to a package of 8 pouch in 1 carton / 1 d in 1 pouch (65162-993-04) of Dotti, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is patch, extended release and is administered via transdermal form.

    Is NDC 65162-993 included in the NDC Directory?

    Yes, Dotti with product code 65162-993 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on February 04, 2019 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 65162-993-08?

    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 65162-993-08?

    The 11-digit format is 65162099308. 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
    5-3-265162-993-085-4-265162-0993-08