Dotti Patch, Extended Release
NDC Package 65162-993-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dotti (estradiol) patches is a medication a female hormone (estrogen). This formulation utilizes a patch, extended release delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-993 and is authorized under FDA application ANDA211293.

Identification & Billing

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
11-Digit Billing Format
65162099308
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dotti
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
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
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
ESTRADIOL .05 mg/d
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211293
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-04-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65162-993-08 identifies a specific commercial 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. This patch, extended release is formulated for transdermal use and contains estradiol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Llc on February 04, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162099308. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65162-993-08
11-Digit CMS (5-4-2)
65162-0993-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.