Afirmelle Kit
NDC Package 65862-849-92
Package Information
Afirmelle (levonorgestrel and ethinyl estradiol) 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 65862-849 and is authorized under FDA application ANDA206886.
Identification & Billing
- RxCUI: 1860414 - {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Afirmelle 28 Day]
- RxCUI: 1860414 - Afirmelle 28 Day Kit
- RxCUI: 242297 - levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet
- RxCUI: 242297 - ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet
- RxCUI: 748797 - inert 1 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 65862 - Aurobindo Pharma Limited
- 65862-849 - Afirmelle
- 65862-849-92 - 6 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
- 65862-849 - Afirmelle
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 (65862-849). Click a package code to view its specific billing and regulatory data.
* 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 65862-849-92 identifies a specific commercial package of 6 pouch in 1 carton / 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Afirmelle, 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 November 14, 2016. 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: a progestin and 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. 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: 65862084992. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
