Amabelz
NDC Package 68180-830-73

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Amabelz is this medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 68180-830 and is authorized under FDA application ANDA203339.

Identification & Billing

NDC Package Code
68180-830-73
Package Description
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK
Product Code
68180-830
11-Digit Billing Format
68180083073
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA

Clinical Specifications

Proprietary Name
Amabelz
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
FDA Application #
ANDA203339
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-21-2016
End Marketing Date
04-30-2022
Listing Expiration
04-30-2022
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68180-830). Click a package code to view its specific billing and regulatory data.

68180-830-13
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (68180-830-11) / 28 TABLET in 1 BLISTER PACK

* 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 68180-830-73 identifies a specific commercial package of 3 pouch in 1 carton / 1 blister pack in 1 pouch / 28 tablet in 1 blister pack of Amabelz, labeled by Lupin Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Lupin Pharmaceuticals, Inc. on October 21, 2016. The current certification is valid through April 30, 2022.

What are the primary indications for this medication?

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.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68180083073. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
68180-830-73
11-Digit CMS (5-4-2)
68180-0830-73

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