Zenchent Fe
NDC Package 65162-347-84

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Zenchent Fe is this combination hormone medication is used to prevent pregnancy. Marketed by Amneal Pharmaceuticals Of New York, Llc, this product is identified by NDC 65162-347 and is authorized under FDA application ANDA078892.

Identification & Billing

NDC Package Code
65162-347-84
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
65162-347
11-Digit Billing Format
65162034784
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk
  • RxCUI: 1095223 - ferrous fumarate 75 MG Chewable Tablet
  • RxCUI: 1095224 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack
  • RxCUI: 1095224 - eth-estra-noreth 0.035-0.4 MG (21) Chewable Tablet / ferr fum 75 MG (7) Chewable Tablet 28 Day Pack
  • RxCUI: 1095224 - {21 (ethinyl estradiol 35 MCG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack
  • RxCUI: 1483558 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack [Zenchent Fe 28 Day]

Clinical Specifications

Proprietary Name
Zenchent Fe
Dosage Form
-
Usage Information
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: norethindrone (a progestin) and ethinyl estradiol (an estrogen). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. There is a small amount of iron (ferrous fumarate) in each of the 7 inactive tablets taken during the fourth week. The inactive pills do not contain any hormones. These tablets are meant to keep you in the habit of taking 1 tablet each day and do not have enough iron to treat iron deficiency. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Of New York, Llc
FDA Application #
ANDA078892
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-26-2011
Listing Expiration
12-31-2017
Exclude Flag
I
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 65162-347-84 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Zenchent Fe, labeled by Amneal Pharmaceuticals Of New York, Llc. 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 Amneal Pharmaceuticals Of New York, Llc on September 26, 2011. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: norethindrone (a progestin) and ethinyl estradiol (an estrogen). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. There is a small amount of iron (ferrous fumarate) in each of the 7 inactive tablets taken during the fourth week. The inactive pills do not contain any hormones. These tablets are meant to keep you in the habit of taking 1 tablet each day and do not have enough iron to treat iron deficiency. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How is this Amneal Pharmaceuticals Of New York, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162034784. 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)
65162-347-84
11-Digit CMS (5-4-2)
65162-0347-84

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