Aurovela Fe Kit
NDC Package 65862-941-58

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

Aurovela Fe (norethindrone acetate and ethinyl estradiol and ferrous fumarate) kits is this combination hormone medication is used to prevent pregnancy. This formulation utilizes a kit delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-941 and is authorized under FDA application ANDA207580.

Identification & Billing

NDC Package Code
65862-941-58
Package Description
5 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (65862-941-87) / 1 KIT in 1 BLISTER PACK
Product Code
65862-941
11-Digit Billing Format
65862094158
RxNorm Crosswalk
  • RxCUI: 1359022 - norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359023 - {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1359023 - Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Aurovela Fe
Non-Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
Dosage Form
Kit - A packaged collection of related material.
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
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207580
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-15-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-941). Click a package code to view its specific billing and regulatory data.

65862-941-88
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT 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 65862-941-58 identifies a specific commercial package of 5 pouch in 1 carton / 1 blister pack in 1 pouch (65862-941-87) / 1 kit in 1 blister pack of Aurovela Fe, a human prescription drug labeled by Aurobindo Pharma Limited. This kit is formulated for use and contains 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 Aurobindo Pharma Limited on June 15, 2017. The current certification is valid through December 31, 2026.

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 Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862094158. 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)
65862-941-58
11-Digit CMS (5-4-2)
65862-0941-58

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